Banned Devices; Proposal To Ban Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove, 15173-15188 [2016-06360]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Proposed Rules]
[Pages 15173-15188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06360]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 878, 880, and 895

[Docket No. FDA-2015-N-5017]
RIN 0910-AH02


Banned Devices; Proposal To Ban Powdered Surgeon's Gloves, 
Powdered Patient Examination Gloves, and Absorbable Powder for 
Lubricating a Surgeon's Glove

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that Powdered Surgeon's Gloves, Powdered Patient Examination 
Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present 
an unreasonable and substantial risk of illness or injury and that the 
risk cannot be corrected or eliminated by labeling or a change in 
labeling. Consequently, FDA is proposing these devices be banned.

DATES: Submit either electronic or written comments by June 20, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-5017 for ``Banned Devices; Proposal to Ban Powdered 
Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable 
Powder for Lubricating a Surgeon's Glove.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of

[[Page 15174]]

comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Elizabeth Claverie-Williams, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 2508, Silver Spring, MD 20993, 
301-796-6298, email: elizabeth.claverie@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. History of Powdered Gloves and Their Regulation
    B. Citizen Petitions
    C. Scope of the Ban
    D. Legal Standard
II. Evaluation of Data and Information Regarding Glove Powder
    A. Summary of Benefits for Devices That FDA Is Proposing To Ban
    B. Summary of Risks for Devices That FDA Is Proposing To Ban
    C. State of the Art
    D. Scientific Literature
    E. Actions of Other Regulatory Entities and Professional 
Organizations
    F. Analysis of Medical Device Adverse Events Reported to FDA for 
Medical Gloves
III. The Reasons FDA Initiated the Proceeding; Determination That 
Powdered Gloves Present an Unreasonable and Substantial Risk of 
Illness
IV. FDA's Determination That Labeling, or a Change in Labeling, 
Cannot Correct or Eliminate the Risk
V. FDA's Determination That the Ban Applies to Devices Already in 
Commercial Distribution and Sold to Ultimate Users, and the Reasons 
for This Determination
VI. Legal Authority
VII. Environmental Impact
VIII. Economic Analysis of Impacts
    A. Introduction
    B. Summary
IX. Proposed Effective Date
X. Paperwork Reduction Act of 1995
XI. Federalism
XII. References

I. Background

    The Medical Device Amendments of 1976 (Pub. L. 94-295) (the 
amendments), amending the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 321 et seq.), became law on May 28, 1976. Among 
other provisions, the amendments added section 516 to the FD&C Act (21 
U.S.C. 360f), which authorizes FDA to ban by regulation any device 
intended for human use if FDA finds, based on all available data and 
information, that such device presents a ``substantial deception'' or 
an ``unreasonable and substantial risk of illness or injury,'' which 
cannot be, or has not been, corrected or eliminated by labeling or a 
change in labeling.
    FDA is proposing to ban powdered surgeon's gloves (21 CFR 
878.4460), powdered patient examination gloves (21 CFR 880.6250), and 
absorbable powder for lubricating a surgeon's glove (21 CFR 878.4480). 
Non-powdered gloves are not included in this ban. In order to clarify 
this distinction, we are proposing to amend the descriptions of these 
devices in the regulations to specify that, if the ban were to be 
finalized, these regulations would apply only to non-powdered gloves. 
FDA's conclusions, which are discussed in this document, are based on 
an evaluation of all available data and information known to the 
Agency. However, to the extent that there is additional information 
that we should consider regarding the risks and benefits of powdered 
gloves, comments should be submitted as described previously.
    The proposed rule would apply to all powdered gloves except 
powdered radiographic protection gloves. FDA has determined that the 
banning standard does not apply to this type of glove. In addition, we 
are not aware of any powdered radiographic protection gloves that are 
currently on the market. The proposed ban would not apply to powder 
used in the manufacturing process (e.g., former-release powder) of non-
powdered gloves, where that powder is not intended to be part of the 
final finished glove. Finished non-powdered gloves are expected to 
include no more than trace amounts of residual powder from these 
processes, and the Agency encourages manufacturers to ensure finished 
non-powdered gloves have as little powder as possible. In our 2008 
Medical Glove Guidance Manual (Ref. 1), we recommended that non-
powdered gloves have no more than 2 milligrams of residual powder and 
debris per glove, as determined by the Association for Testing and 
Materials (ASTM) D6124 test method (Ref. 2). The Agency continues to 
believe this amount is an appropriate maximum level of residual powder, 
but may reevaluate this amount if more information becomes available. 
The proposed ban would also not apply to powder intended for use in or 
on other medical devices, such as condoms. FDA has not seen evidence 
that powder intended for use in or on other medical devices, such as 
condoms, presents the same public health risks as that on powdered 
medical gloves.

A. History of Powdered Gloves and Their Regulation

    Medical gloves play a significant role in the protection of both 
patients and health care personnel in the United States. Health care 
personnel rely on medical gloves as barriers against transmission of 
infectious diseases and contaminants when conducting surgery, as well 
as when conducting more limited interactions with patients.
    Various types of powder have been used to lubricate gloves so that 
wearers could don the gloves more easily. The first lubricant powder 
used to aid in surgical glove donning, introduced in the late 
nineteenth century, was composed of Lycopodium spores (club moss 
spores) or ground pine pollen (Refs. 3 and 4). By the 1930s, Lycopodium 
powder was recognized to cause wound granulomas and adhesion formation 
and was replaced by talcum powder (chemically hydrous magnesium 
silicate), a nonabsorbable lubricant powder. In the 1940s, talcum 
powder (talc) was also recognized to be a cause of postoperative 
adhesions and granuloma formation. In 1947, modified cornstarch powder 
was introduced as an absorbable and non-irritating glove powder, and it 
largely replaced talc as a donning lubricant for surgical gloves by the 
1970s. Cornstarch is currently the most commonly used type of 
absorbable glove powder.
    In the 1980s, preventing the transmission of acquired 
immunodeficiency syndrome (AIDS) became a major public health concern. 
The Centers for Disease Control and Prevention (CDC) recommended that 
health care workers use appropriate barrier precautions to prevent 
exposure to the human immunodeficiency virus (HIV) and other bloodborne 
pathogens. Responding to heightened concerns about cross-contamination 
between patients and health care workers, in the Federal Register of 
January 13, 1989 (54 FR 1602), FDA revoked the exemption for patient 
examination gloves from certain current good manufacturing practice 
requirements in order to ensure that manufacturers provide an 
acceptable manufacturing quality level. FDA similarly revoked the 
exemption from premarket notification

[[Page 15175]]

requirements for patient examination gloves.
    On December 12, 1990, FDA published regulations describing certain 
circumstances under which surgeon's and patient examination gloves 
would be considered adulterated (55 FR 51254). The regulations 
established the sampling plans and test methods for glove leakage 
defects that we would use to determine whether gloves were adulterated 
(see 21 CFR 800.20). These sampling plans and test methods were further 
updated in 2006 (December 19, 2006, 71 FR 75865 at 75876). 
Subsequently, we initiated inspections of glove manufacturers to ensure 
conformance with the acceptable quality levels identified in the 
regulation.
    In 1997, FDA issued its Medical Glove Powder Report (Ref. 5), which 
described the risks presented by glove powder and the state of the 
medical glove market at that time. We reviewed the clinical and 
experimental data on the risks and adverse events associated with the 
use of powder on surgical and medical gloves available at that time in 
the medical literature. We also reviewed the information in our 
MedWatch database on the adverse events associated with the use of 
powdered gloves. In addition, the Agency reviewed the commercial 
information available at that time on sources for medical gloves, 
relative numbers and types of gloves, and the costs of different glove 
types. FDA found that glove powder could cause inflammation and 
granulomas, and that aerosolized glove powder on natural rubber latex 
(NRL) gloves can carry allergenic proteins that have the potential to 
cause respiratory allergic reactions.
    Even though the Agency was aware of certain health risks presented 
by glove powder, based on the totality of information available in 
1997, the Agency opted not to initiate a ban. At the time, use of 
chlorination was the most common alternative to powder for the purpose 
of lubricating NRL surfaces. However, the chlorination process was 
recognized to cause physical damage to gloves and to alter the physical 
properties of treated gloves if not performed properly (Ref. 5). In 
1997, FDA was concerned that widespread use of glove chlorination would 
compromise some of the mechanical and physical properties of gloves 
including shelf life, grip, and in-use durability, since these were 
widely recognized risks of poorly managed chlorination processes. 
Polymer coatings to replace glove powder for glove lubrication had been 
developed but, because of their increased cost, were not yet in 
widespread use at the time. The report concluded that banning powdered 
gloves in 1997 would cause a market shortage of medical gloves, which 
could result in inferior glove products and increased costs to the U.S. 
health care system due to a lack of immediate availability of suitable 
alternatives.
    We identified two options in 1997: (1) Provide adequate information 
for the consumer to make an informed decision by, among other things, 
requiring that the amount of water-soluble NRL proteins and the amount 
of glove powder present in powdered gloves be stated on the product 
label and establishing upper limits for the amount of these substances 
allowed in gloves, or (2) initiate the process to ban glove powder at 
some predetermined time in the future and require manufacturers to 
convert to powder-free production or provide safety data, including 
foreign body and airborne allergen concerns, by a certain date.
    At that time, the Agency determined that the first option was 
preferable and issued the draft guidance entitled ``Draft Guidance for 
Industry and FDA Staff: Medical Glove Guidance Manual'' on July 30, 
1999 (Ref. 6). In addition to other changes, including the natural 
rubber latex caution statement for gloves made of NRL, this document 
advised industry that FDA recognized the newly issued consensus 
standard ASTM D6124, ``Standard Test Method for Residual Powder on 
Medical Gloves,'' which established an accepted method to measure 
residual powder or debris on medical gloves (Ref. 2). In the draft 
guidance, we recommended that medical gloves have no more than 2 mg of 
residual powder or debris per glove in order to label that glove as 
``powder-free.'' Since 1999, gloves with low amounts of residual powder 
after manufacturing have been referred to as ``powder-free'' or 
``powderless.'' Such gloves may have residual powder from the 
manufacturing process removed by washing and chlorination, and they may 
be coated with a polymer to aid donning. For comparison, powdered 
medical gloves contain approximately 120 to 400 mg of residual 
particulates, mold release, and donning powder.
    In addition to the draft guidance issued in 1999, in the same issue 
of the Federal Register, FDA proposed regulations to reclassify all 
surgeon's and patient examination gloves as class II medical devices 
(July 30, 1999, 64 FR 41710). While the proposed rule was never 
finalized, the preamble provided FDA's rationale for choosing not to 
initiate a ban for powdered surgeon's and patient examination gloves at 
the time. We explained that: (1) A ban would not address exposure to 
natural latex allergens from medical gloves with high levels of natural 
latex proteins; (2) a ban of powdered gloves might compromise the 
availability of high quality medical gloves; and (3) a ban of powdered 
gloves might greatly increase annual costs by almost as much as $64 
million over the alternative approach proposed by FDA in the ``Draft 
Guidance for Industry and FDA Staff: Medical Glove Guidance Manual.''
    FDA did not finalize the 1999 Draft Guidance. The Draft Guidance 
was withdrawn when we issued our ``Guidance for Industry and FDA 
Staff--Medical Glove Guidance Manual,'' on January 22, 2008 (Ref. 1). 
Recognition and use of ASTM D6124 to reduce the powder burden on 
medical gloves continued in the revised guidance. Since we issued the 
draft guidance in 1999, the number of adverse events reported to FDA 
related to glove use and the number of powdered glove devices seeking 
premarket clearance have decreased.

B. Citizen Petitions

    FDA has received several citizen petitions regarding the use of 
glove powder. In 1998, a citizen petition was submitted by Public 
Citizen requesting that FDA ban the use of cornstarch powder in the 
manufacture of latex surgeon's and patient examination gloves (see 
Docket No. FDA-2008-P-0531). While there was scientific evidence in 
1998 that indicated that the use of glove powder was associated with 
negative health consequences (partly due to the ability of glove powder 
to facilitate sensitization of health care workers to NRL and partly 
due to adverse effects due only to contact with glove powder), as 
discussed previously, quality concerns, the lack of suitable 
alternatives, and costs weighed against FDA initiating the process to 
remove powdered gloves from the market. Moreover, the impact of 
reductions in the amount of NRL protein used in gloves and in the 
amount of powder added to gloves, which were being done as means to 
mitigate the risk of health care worker sensitization to NRL, had not 
yet been studied for a reasonable length of time. As a result of these 
considerations, we did not grant the 1998 petition to ban the use of 
glove powder.
    Approximately a decade later, between 2008 and 2011, FDA received 
three petitions requesting, among other things, that the Agency ban the 
use of cornstarch powder on NRL and synthetic latex surgical and 
examination gloves (FDA-2008-P-0531-0001, FDA-2009-P-0117-0001, and 
FDA-2011-P-

[[Page 15176]]

0331-0001). These petitions prompted us to evaluate new data on the 
risks of using powdered gloves, to consider new information regarding 
the current availability and costs of alternatives to glove powder for 
glove lubrication, and to reassess the frequency of use of powdered 
medical gloves. As a result of these petitions, FDA published in 2011 
in the Federal Register a document requesting comments related to the 
risks and benefits of powdered gloves (February 7, 2011, 76 FR 6684; 
FDA-2011-N-0027). In addition, although we believed that additional 
labeling would not correct or eliminate the risks associated with glove 
powder, we decided that it was important to inform consumers about the 
risks of powdered gloves while FDA assessed whether glove powder had 
benefits that might affect the determination of whether or not a ban on 
the devices was appropriate at this time. Accordingly, on February 7, 
2011, FDA issued the draft guidance entitled ``Draft Guidance for 
Industry and FDA Staff: Recommended Warning for Surgeon's Gloves and 
Patient Examination Gloves that Use Powder,'' which proposed a general 
voluntary warning for powdered glove devices, regardless of whether the 
devices were surgeon's gloves or patient examination gloves (Ref. 7). 
As we reviewed the comments received on the benefits and risks of glove 
powder, we determined that a ban on powdered gloves is appropriate and 
determined not to finalize the draft guidance. This draft guidance was 
withdrawn on May 6, 2015 (80 FR 26059) as part of a mass withdrawal 
effort to remove draft guidance documents issued before 2014 that have 
not been finalized. When final, this rule will address the risks of 
powdered gloves that were addressed in the draft guidance.

C. Scope of the Ban

    FDA is proposing to ban the following devices: (1) Powdered 
surgeon's gloves (21 CFR 878.4460), (2) powdered patient examination 
gloves (21 CFR 880.6250), and (3) absorbable powder for lubricating a 
surgeon's glove (21 CFR 878.4480).
    Because the classification regulations for these device types do 
not distinguish between powdered and non-powdered versions, FDA is 
proposing to amend the descriptions of these devices in the regulations 
to specify that, if this proposed ban is finalized, these regulations 
will apply only to non-powdered gloves while the powdered version of 
each type of glove will be added to 21 CFR 895 Subpart B--Listing of 
Banned Devices.

D. Legal Standard

    Section 516(a)(1) of the FD&C Act authorizes FDA to ban a device 
intended for human use by regulation if it finds, on the basis of all 
available data and information, that such a device ``presents 
substantial deception or an unreasonable and substantial risk of 
illness or injury.'' A banned device is adulterated under section 
501(g) of the FD&C Act (21 U.S.C. 351(g)).
    In determining whether a deception or risk of illness or injury is 
``substantial,'' FDA will consider whether the risk posed by the 
continued marketing of the device, or continued marketing of the device 
as presently labeled, is important, material, or significant in 
relation to the benefit to the public health from its continued 
marketing (see 21 CFR 895.21(a)(1)). Although FDA's device banning 
regulations do not define ``unreasonable risk,'' in the preamble to the 
final rule promulgating 21 CFR part 895, we explained that, with 
respect to ``unreasonable risk,'' it ``will conduct a careful analysis 
of risks associated with the use of the device relative to the state of 
the art and the potential hazard to patients and users'' (44 FR 29214 
at 29215, May 18, 1979). The state of the art with respect to this 
proposed rule relates to current technical and scientific knowledge and 
medical practice as it pertains to the various medical gloves that are 
used when treating patients.
    Thus, in determining whether a device presents an ``unreasonable 
and substantial risk of illness or injury,'' FDA analyzes the risks and 
the benefits the device poses to patients and, in the case of powdered 
gloves, other individuals who come in contact with these devices, by 
comparing those risks and benefits to the risks and benefits posed by 
alternative devices and/or treatments being used in current medical 
practice. Actual proof of illness or injury is not required; we need 
only find that a device presents the requisite degree of risk on the 
basis of all available data and information (H. Rep. 94-853 at 19; 44 
FR 29215).
    Whenever FDA finds, on the basis of all available data and 
information, that the device presents substantial deception or an 
unreasonable and substantial risk of illness or injury, and that such 
deception or risk cannot be, or has not been, corrected or eliminated 
by labeling or by a change in labeling, FDA may initiate a proceeding 
to ban the device (see 21 CFR 895.20). If FDA determines that the risk 
can be corrected through labeling, FDA will notify the responsible 
person of the required labeling or change in labeling necessary to 
eliminate or correct such risk (see 21 CFR 895.25).
    Section 895.21(d) requires this proposed rule to summarize: (1) The 
Agency's findings regarding substantial deception or the unreasonable 
and substantial risk of illness or injury; (2) the reasons why FDA 
initiated the proceeding; (3) the evaluation of the data and 
information FDA obtained under provisions (other than section 516) of 
the FD&C Act, as well as information submitted by the device 
manufacturer, distributer, or importer, or any other interested party; 
(4) the consultation with the classification panel; (5) the 
determination that labeling, or a change in labeling, cannot correct or 
eliminate the deception or risk; (6) the determination of whether, and 
the reasons why, the ban should apply to devices already in commercial 
distribution, sold to ultimate users, or both; and (7) any other data 
and information that FDA believes are pertinent to the proceeding.
    We have grouped some of these together within broader categories 
and address them in the following order:
     Evaluation of data and information regarding glove powder, 
including data and information FDA obtained under provisions other than 
section 516 of the FD&C Act, information submitted by the device 
manufacturer and other interested parties, the consultation with the 
classification panel, and other data and information that FDA believes 
are pertinent to the proceeding, with respect to:

[cir] Benefits
[cir] Risks
[cir] State of the Art

     The reasons FDA initiated the proceeding, our 
determination that glove powder presents an unreasonable and 
substantial risk of illness or injury (FDA has not made a finding 
regarding substantial deception);
     FDA's determination that labeling, or a change in 
labeling, cannot correct or eliminate the risk; and
     FDA's determination that the ban applies to devices 
already in commercial distribution and sold to ultimate users, and the 
reasons for this determination.

II. Evaluation of Data and Information Regarding Glove Powder

    A thorough review of the information that has become available 
since FDA issued the Medical Glove Powder Report in 1997 (Ref. 5) 
supports FDA's conclusion that powdered surgeon's gloves, powdered 
patient examination gloves, and absorbable powder for

[[Page 15177]]

lubricating a surgeon's glove should be banned. As discussed in the 
paragraphs that follow, FDA has concluded that the risks posed by 
powdered gloves, including health care worker and patient sensitization 
to NRL allergens, surgical complications related to peritoneal 
adhesions, and other adverse health events not necessarily related to 
surgery, such as inflammatory responses to glove powder, outweigh the 
benefits that these devices pose to patients. FDA's position is 
bolstered when the state of the art for medical gloves is considered, 
which includes viable non-powdered alternatives that do not carry any 
of the risks associated with glove powder. Further, unlike when this 
decision was considered previously, FDA believes that this ban would 
likely have minimal economic and shortage impact on the health care 
industry. Thus, a transition to alternatives in the marketplace should 
not result in any detriment to public health.
    In reaching the conclusions that form the basis for this proposed 
rule, FDA considered evidence from multiple sources. FDA re-examined 
the 1997 Report on Medical Glove Powder (Ref. 5) along with its 
scientific and clinical literature references, its analysis of reported 
adverse events due to the use of gloves, and its analysis of glove 
market availability (Ref. 5). In addition, we performed a more 
contemporary analysis of relevant scientific literature and of adverse 
events related to medical glove use from 1992 through 2014 and obtained 
new market availability data on medical glove use by type. We also 
reviewed the information contained in related citizen petitions, as 
well as the comments associated with the petitions. Further, the Agency 
reviewed the public statements and actions of other U.S. government 
Agencies, U.S. health care organizations, and of foreign governments 
concerning powdered natural rubber latex gloves.
    The sections that follow discuss the information that FDA evaluated 
as part of the decision to propose this ban. Sections II.A and II.B 
provide a concise summary of the benefits and risks that FDA believes 
are posed by the use of powdered gloves. Section II.C provides a 
discussion on the state of the art as it pertains to medical gloves. 
Sections II.D, II.E, and II.F provide detailed discussions of the 
scientific literature, actions of other regulatory and professional 
organizations, and adverse event reports that formed the basis of the 
summaries in sections II.A and II.B.

A. Summary of Benefits for Devices That FDA Is Proposing To Ban

    To help determine whether powdered gloves present an unreasonable 
and substantial risk of illness or injury, FDA issued a notice in the 
Federal Register requesting public input on the risks and benefits of 
powdered gloves (February 7, 2011, 76 FR 6684; FDA-2011-N-0027). FDA 
received nearly 300 comments to the docket, the large majority of which 
addressed the continuing risks associated with the use of powdered 
gloves, which are discussed later in this document. Comparatively, very 
few comments addressed the benefits of gloves that are powdered, and 
the benefits that were addressed were minimal. The primary benefits 
described in the comments were almost entirely related to greater ease 
of donning and doffing gloves and decreased tackiness of gloves 
packaged together. These benefits apply to both powdered surgeon's 
gloves and powdered patient examination gloves. The benefits of 
absorbable powder for lubricating a surgeon's glove derive from the 
benefits of powdered surgeon's gloves, which include ease of donning 
and doffing gloves and decreased tackiness.
    Some studies have reported that alternatives to powdered gloves, 
such as vinyl gloves, may not provide as good of dexterity and 
biological impermeability as NRL gloves (Ref. 8). However, this 
proposed ban does not include non-powdered NRL gloves, which offer the 
same performance characteristics of powdered NRL gloves, and several 
studies have found that alternatives, such as nitrile and neoprene 
gloves, offer the same level of protection, dexterity, and performance 
as NRL gloves (Ref. 9 to 14). Thus, the only benefits to using powdered 
gloves that FDA has been able to identify is a greater ease of donning 
and doffing and decreased tackiness of gloves packaged together.

B. Summary of Risks for Devices That FDA Is Proposing To Ban

    Although some risks of these devices are similar for all glove 
types, the level and types of risks presented by powdered gloves can 
vary depending on the composition of the glove (synthetic versus NRL) 
and its indicated uses (surgeon's glove versus patient examination 
glove). While we acknowledge that powdered synthetic patient 
examination gloves present less risk than powdered NRL surgeon's 
gloves, we concluded that the risks posed by either of these glove 
types is unreasonable and substantial in relation to the minimal 
benefits that powdered gloves offer, especially when considering the 
benefits and risks posed by readily available alternative devices 
(discussed in section II.C). The identified risks of powdered gloves 
are as follows:
1. Risks of Absorbable Powder for Lubricating a Surgeon's Glove
    The powder used for lubricating a surgeon's glove, which is often 
used to lubricate patient examination gloves as well, presents risks 
not only to the user and patient, but also to other individuals that 
might be exposed to it. This powder, often referred to as Absorbable 
Dusting Powder or ADP, has been shown to cause acute severe airway 
inflammation, granulomas, and adhesions. These risks are present before 
the glove is lubricated with the powder. Then, during the lubrication 
process, the powder particles may absorb harmful contaminants (Ref. 
15). As mentioned previously, the risks presented by glove powder can 
vary depending on the type of glove on which it is used. When used on 
NRL gloves, powder has the ability to adhere to latex allergenic 
proteins that, when aerosolized and inhaled, present significant risks 
to patients, including inflammatory responses, hypersensitivity 
reactions, and allergic reactions (see risks on powdered NRL gloves in 
the paragraphs that follow). Additionally, latex sensitive individuals 
can experience cutaneous reactions upon skin exposure to the latex 
allergenic proteins adherent to the powder (Refs. 15 and 16). These 
consequences of powder may persist even after patients or health care 
workers are no longer in contact with the powder. Risks such as 
allergic reactions, granulomas, and adhesions can be long-lasting, and 
may not be mitigated by removing powder after exposure (Refs 17 to 19).
2. Risks of Powdered Natural Rubber Latex Gloves
    When absorbable dusting powder is used on NRL gloves, the 
combination presents specific risks that apply to both surgeon's and 
patient examination gloves. The powder used to lubricate these gloves 
may bind to natural rubber latex proteins. The powder carries the latex 
protein, resulting in a latex aerosol whenever health care workers put 
on or remove the gloves. Clinical and laboratory studies indicate that 
glove powder facilitates impaired respiratory function due to allergic 
and inflammatory responses to NRL in health care personnel and in 
animals exposed to glove powder because

[[Page 15178]]

aerosolized powder particles carrying NRL antigens into the health care 
environment and the respiratory tracts of exposed health care personnel 
and patients make NRL sensitization a much more efficient process than 
it would be in the absence of glove powder (Ref. 8, 20 to 23). As a 
result, health care workers that are sensitive to latex occasionally 
develop allergic reactions when they inhale too much powder. 
Sensitization to latex and subsequent allergic reactions also may 
result from exposure to aerosolized powder carrying the NRL proteins 
(Ref. 24). Allergic reactions include asthma, allergic rhinitis, 
conjunctivitis, and dyspnea. As discussed in the paragraphs that 
follow, the majority of studies suggest that use of low NRL protein 
powder-free gloves significantly reduces occupational asthma and the 
incidence of individuals developing allergies to NRL in the health care 
workplace (Refs. 21, 23, 25 to 35).
3. Risks of Powdered Synthetic Surgeon's Gloves
    Although powdered synthetic surgeon's gloves do not present the 
risk of allergic reactions due to aerosolized powder that is carrying 
latex, the use of powdered synthetic gloves still presents the risk of 
exposing individuals to the powder via inhalation, which can lead to 
airway inflammation. Additionally, use of these gloves by health care 
providers can expose patients' tissues during surgery and invasive 
examinations to deposits of glove powder, which could then result in 
granuloma formation in any exposed site, as well as peritoneal and 
other tissues adhesions. Recent studies show that cornstarch glove 
powder causes peritoneal adhesion formation and granulomatous reactions 
in experimental animal models (Refs. 24, 36 to 39) as well as in 
exposed patient tissues with resulting patient injury (Refs. 40 and 
41). In addition to risk of powder-induced adhesion formation, many in 
vitro and animal studies have shown the adverse effects of glove powder 
on wound healing, including increases in wound inflammation (Refs. 42 
to 44). These studies indicate that powder may promote infection in 
wounds, which can lead to wound healing complications.
4. Risks of Powdered Synthetic Patient Examination Gloves
    Although the powder on patient examination gloves is not exposed to 
internal organs during surgery, these gloves still present a 
substantial risk of illness or injury because they are nevertheless 
exposed to internal tissue when employed in procedures such as oral, 
vaginal, gynecological, and rectal examinations. Powder may be 
introduced to the female reproductive tract during gynecological exams 
(Refs. 45 to 47), which may lead to female reproductive complications 
(Refs. 18, 48 to 50). The migration of powder into the reproductive 
tract was demonstrated in an animal model and human clinical studies 
(Refs. 21, 40, 51). The wearers of these gloves can also facilitate the 
migration of powder from these gloves into the body when handling 
instruments such as endoscopes or when performing postsurgical wound 
care. Thus, the powder on synthetic patient exam gloves presents risks 
similar to those of the powder on synthetic surgeon's gloves, including 
granulomas and adhesions, and the resulting complications. Finally, as 
with synthetic surgeon's gloves, powdered patient examination gloves 
also can expose those in their proximity to the risk of powder 
inhalation, even if not carrying NRL.

C. State of the Art

    FDA has considered the reasonableness of the risks of powdered 
surgeon's gloves, powdered patient examination gloves, and absorbable 
powder for lubricating a surgeon's gloves relative to the state of the 
art, i.e., the state of technical and scientific knowledge and modern 
practices of medicine, for medical protective gloves (see 44 FR 29214; 
May 18, 1979). Given that alternatives are readily available that do 
not carry the risks posed by powdered gloves, we have concluded that 
powdered gloves now lag behind the state of the art. As discussed 
further in sections II.D and II.E, this conclusion is illustrated both 
by market trends indicating that the health care industry is moving to 
non-powdered alternatives and by the actions of certain regulatory 
entities and professional organizations that have banned or restricted 
the use of glove powder.
    Over the last two decades FDA has observed a progressive increase 
in the use of non-powdered gloves. Since 1998, medical glove 
manufacturers have developed a variety of non-powdered gloves, which 
can be made from various materials, including NRL, polyvinyl chloride, 
nitrile, and neoprene. Both non-powdered patient examination and non-
powdered surgeon's gloves are currently marketed. These alternatives 
are readily available at similar costs to powdered gloves. As a result, 
both industry and glove users appear to be shifting away from the use 
of powdered gloves, which has led to an increase in the manufacturing 
and usage of alternative non-powdered gloves. Annual sales figures from 
2000 through 2008 indicate a consistent increase in non-powdered 
surgeon's and patient examination glove sales as a percent of total 
glove sales, and recent projections of annual gloves sales indicate 
that at least 93 percent of medical providers have switched to non-
powdered gloves (Ref. 52).
    These trends can be at least partially attributed to scientific 
studies that have been conducted in this area that have helped raise 
public awareness of powder-induced latex hypersensitivity, peritoneal 
adhesions, granulomas, and other adverse events that can result from 
using powdered gloves. These trends can also be partially attributed to 
increased public awareness resulting from the availability of studies 
that have examined the effects of glove powder and the public health 
benefits that result from its removal from the market, along with 
industry initiatives to improve donning, doffing, and protection of 
non-powdered gloves, which have helped to move the state of the art 
forward to the use of alternative non-powdered gloves.
    As described previously, some users of powdered gloves have noted 
ease of donning or doffing as a benefit over non-powdered gloves. 
However, a study of various brands of powdered and non-powdered NRL 
gloves by Cote et al. found that there are non-powdered latex gloves 
that are easily donned with wet or dry hands with relatively low force 
compared to the forces required to don powdered latex examination 
gloves (Ref. 53). Additional non-powdered alternatives to powdered 
gloves include synthetic gloves, which are traditionally non-powdered 
and offer similar levels of performance to powdered gloves and non-
powdered NRL gloves (Refs. 9, 14, 54).
    Studies that have examined the effects of removing powdered gloves 
from health care environments have shown that removing these devices 
consistently results in a reduction of the types of adverse events 
associated with glove powder. Korniewicz et al. examined the effect of 
conversion from powdered NRL surgical gloves to non-powdered NRL 
surgical gloves on operating room personnel (Ref. 32). This study found 
that conversion to non-powdered NRL gloves reduced adverse events 
related to exposure to NRL, including a significant decrease in skin 
and upper respiratory symptoms. During the course of the study, the 
authors also evaluated user satisfaction for non-powdered gloves and 
found that users rated their satisfaction, on average, the same or 
better than before conversion from powdered gloves to non-powdered

[[Page 15179]]

gloves in categories including quality, comfort, safety, performance, 
standardization, and needle stick injuries.
    In another study on the effects of eliminating powdered NRL gloves 
from a hospital, Allmers et al. found that eliminating powdered NRL 
gloves reduced aerogenic NRL allergen loads and allowed latex-
sensitized or latex-allergic health care workers to continue working 
(Ref. 25). Allmers et al. further assessed the effects of switching to 
non-powdered NRL gloves on the incidence of NRL allergy in personnel 
working in multiple health care facilities insured by the German 
Professional Association for Health Services and Welfare (Ref. 27). 
This study concluded that there was a significant correlation between 
an increase in the purchase of non-powdered NRL gloves and a decline in 
NRL-induced occupational asthma. In a subsequent study, Allmers et al. 
further showed that a reduction in the use of powdered NRL gloves 
correlated with a dramatic decline in reported NRL-induced occupational 
skin disease (Ref. 26). The authors of these studies concluded that 
removing powdered NRL gloves from health care environments successfully 
reduced the development of NRL-induced allergies. These observations 
have been confirmed by several other studies that are described further 
in section II.D (Refs. 21, 30, 32 to 35, 55).
    FDA also expects that the removal of powdered gloves from health 
care environments will reduce the risks of using powdered synthetic 
gloves, such as granuloma formation in any exposed site, as well as 
peritoneal and other tissues adhesions. As discussed previously, recent 
literature has shown that cornstarch glove powder causes peritoneal 
adhesion formation and granulomatous reactions in experimental animal 
models (Refs. 24, 36 to 39) as well as in exposed patient tissues with 
resulting patient injury (Refs. 40 and 41). In addition to risk of 
powder-induced adhesion formation, many in vitro and animal studies 
have shown the adverse effects of glove powder on wound healing, 
including increases in wound inflammation (Refs. 42 to 44). Non-
powdered gloves do not carry these risks, and their exclusive use 
should greatly reduce the risk of these adverse health effects in 
health care settings.
    In comparison to the evidence considered in 1997, FDA has concluded 
that this proposed ban would likely have minimal economic and shortage 
impact on the health care industry, such that, if they have not 
already, health care entities that currently use powdered gloves should 
have little trouble transitioning to non-powdered alternatives. As 
described previously, there are many readily available alternatives to 
powdered gloves that provide similar or better protection and utility 
without the risks associated with powdered gloves, and available market 
projections and data have shown that these alternatives that represent 
the state of the art have already resulted in a shift away from 
powdered gloves. Further, more studies are now available on the 
positive health benefits associated with the restriction or elimination 
of the use of powdered gloves in health care environments where they 
were previously prevalent. Based on an examination of all these 
factors, FDA has determined that the state of the art, i.e., the state 
of technical and scientific knowledge and modern practices of medicine, 
has moved beyond the use of powdered gloves in the health care 
industry.

D. Scientific Literature

    In 1997, FDA issued the Medical Glove Powder Report (Ref. 5), 
discussing the potential adverse health effects of medical glove 
powder, along with alternatives and market information available at 
that time. Adverse health events documented in the scientific 
literature review section of the Medical Glove Powder Report included a 
discussion on aerosolized glove powder on NRL gloves carrying 
allergenic proteins that efficiently sensitized health care providers 
to NRL antigens. This exposure subsequently triggered respiratory 
allergic reactions including asthma and allergic rhinitis, 
conjunctivitis, and dyspnea. In addition, as discussed previously, the 
powdered gloves of health care providers expose patients to certain 
risks, including granuloma formation, as well as peritoneal and other 
tissue adhesions when exposed during surgery or an invasive procedure.
    Since the publication of the Medical Glove Powder Report, there 
have been additional scientific studies published regarding the risks 
related to the use of medical glove powder. Many of these references 
were submitted to the Agency in support of the petitions received in 
2008, 2009, and 2011. We also performed our own review of the 
scientific literature to ensure that all available evidence, including 
all available scientific evidence, was considered in its decision-
making process. The most relevant articles gathered from these sources 
are briefly summarized in this document.
    Clinical and laboratory studies published after 1998 still indicate 
that glove powder facilitates impaired respiratory function due to 
allergic and inflammatory responses to NRL in health care personnel and 
in animals exposed to glove powder because aerosolized powder particles 
carrying NRL antigens into the health care environment and the 
respiratory tracts of exposed health care personnel and patients make 
NRL sensitization a much more efficient process than it would be in the 
absence of glove powder (Refs. 8, 20 to 23). The newer studies also 
continue to show that cornstarch glove powder causes adhesion formation 
and granulomatous reactions in experimental animal models (Refs. 24, 36 
to 39), as well as in exposed patient tissues with resulting patient 
injury (Refs. 40 and 41).
    In vitro and animal studies continue to show the adverse effects of 
glove powder on experimental wound healing, including increases in 
wound inflammation (Refs. 42 to 44). Most importantly, since 1997, more 
data have become available on the positive health benefits associated 
with the restriction or elimination of the use of powdered gloves in 
health care environments where they were previously permitted. We 
reviewed studies from clinics and hospitals that have converted to 
either non-powdered NRL gloves or to powder-free gloves of all 
materials. These studies reported reductions in NRL allergy development 
and respiratory symptoms among health care workers (Refs. 20, 21, 23, 
25 to 27, 29 to 34, 39). Although this has not been a universal 
finding, FDA recognizes the positive association between decreased 
usage of glove powder, especially on NRL gloves, and decreased adverse 
health events in the health care setting.
    Epidemiological studies comparing the adverse health events and 
economic consequences in health care settings before and after 
conversion to powder-free gloves have limitations, such as the size of 
studies, the endpoint data collected, and the different populations 
studied. Some studies include the period before the amount of NRL 
protein in surgical and examination gloves was reduced. Others were 
performed abroad where U.S. regulations do not apply and the amounts of 
NRL protein and powder remaining on gloves are not stated. Despite 
these limitations, the preponderance of evidence suggests that use of 
low NRL protein powder-free gloves significantly reduces occupational 
asthma and the incidence of individuals developing allergies to NRL in 
the health care workplace (Refs. 20, 21, 23, 25 to 27, 29 to 34, 39). 
Importantly, these studies did not report

[[Page 15180]]

difficulty in replacing powdered gloves with non-powdered ones and did 
not note any decrease in glove performance in the replacement gloves 
(Refs. 32, 53).
    Charous et al. (Ref. 20) reported in 2000 that a dental office was 
able to reduce airborne NRL antigen levels to undetectable levels with 
the exclusive use of non-powdered NRL gloves, permitting a highly 
sensitized staff member to continue to work there. Also in 2002, Kujala 
et al. (Ref. 22) studied NRL gloves agitated in laboratory test 
chambers and found that the concentration of airborne NRL allergens 
correlated with high levels of airborne glove powder rather than with 
the NRL antigen concentrations in the medical glove material. In 
addition, Ahmed et al. (Ref. 8) reviewed the literature to 2004 on 
occupational NRL allergy and concluded that the use of low NRL protein 
powder-free gloves reduced symptoms and markers of sensitization in 
hospitals that had removed powdered NRL gloves from their workplaces; 
however, they noted that alternatives such as nitrile and vinyl gloves 
may not provide as good dexterity and biological impermeability as 
natural rubber latex gloves. The practicality of using non-powdered 
gloves was studied in 1998 by Cote et al. (Ref. 53) who performed a 
prospective randomized trial measuring the force required for 
volunteers to don various gloves in the laboratory without tearing the 
glove. They concluded that there were available powder-free gloves that 
can be donned easily with forces that are comparable to those required 
for powdered glove donning.
    Individual hospitals, health care systems, regional authorities and 
countries have evaluated the extent of NRL allergies among their staff 
and the effects of removing glove powder from the gloves used in their 
facilities. In 1998, Handfield-Jones (Ref. 56) found that at least 0.9 
percent of health care workers in an English district general hospital 
had confirmable NRL allergies. Anecdotal accounts suggested that 
problems had worsened as glove use increased. Allmers et al. (Ref. 25) 
in 1998 reported a prospective study in a single hospital in Germany to 
evaluate the effect of eliminating powdered NRL gloves from the 
workplace and also giving NRL-free gloves to sensitized workers. Six of 
seven sensitized health care workers showed a decrease in NRL-specific 
Immunoglobulin E antibody concentration during followup after the 
elimination of powdered NRL gloves in that hospital. Two other health 
care workers were able to stop using asthma medication and antiallergic 
drugs. The study authors concluded that eliminating powdered NRL gloves 
reduced aerogenic NRL allergen loads and allowed sensitized or allergic 
health care workers to continue working.
    Not every physician or locality was equally concerned about the 
risk associated with the use of glove powder. In 1999, Sellar and 
Sparrow (Ref. 57) surveyed ophthalmologists in northern England and 
found that, despite relatively high awareness of risks associated with 
powdered glove use during ophthalmic surgery, such as sterile 
endophthalmitis or iritis in patients, up to 15 percent of surveyed 
United Kingdom ophthalmic surgeons were using powdered gloves in their 
surgical practices. However, in 2000, Petsonk (Ref. 58) found that the 
role of glove powder in binding and transferring NRL antigens was 
widely acknowledged in the scientific literature and noted that 
interventions, such as limiting the use of glove powder, seemed likely 
to result in a decline in the prevalence of NRL allergies. 
Additionally, in 2000, Jackson et al. (Ref. 31) reported that 70 
hospitals in the United States and 3 in Europe had registered on an 
Internet Web site as institutions using only powder-free gloves; 
however, the article did not specify whether these hospitals had 
removed only NRL powdered gloves from their workplaces or whether 
synthetic latex powdered gloves were removed from use as well, and the 
Web site is no longer registered. The conclusion of Jackson et al. was 
that the leadership shown by the hospitals that registered as not using 
powdered gloves should serve as a catalyst for FDA to ban the use of 
cornstarch on examination and surgical gloves.
    In 2001, Liss and Tarlo (Ref. 33) reviewed the number of allowed 
occupational asthma claims in health care workers reported to the 
Ontario Workplace Safety and Insurance Board over time as the 
replacement use of powder-free synthetic latex or low protein NRL 
gloves was encouraged, starting in 1996, throughout the province of 
Ontario. Reported health care-related occupational asthma claims ranged 
from 7 to 11 per year during 1991 to 1994 and fell to 1 to 2 claims per 
year in 1997 to 1999 as exposure to powdered NRL gloves decreased. 
Tarlo et al. (Ref. 55) also reported on the experience with 
occupational allergy to NRL in an Ontario teaching hospital network of 
two hospitals. In this hospital system, the number of workers 
identified with NRL allergy each year rose from 1 in 1988 to 6 in 1993 
and to 25 in 1994 after staff education and surveillance for the 
manifestations of NRL allergy. Powder-free, low protein NRL gloves 
replaced non-sterile gloves in 1995 in this hospital system, after 
which new workers with reported NRL allergy dropped to eight in 1995, 
to three in 1997 and to one in 1999. NRL allergy-related time lost from 
work and workers' compensation claims fell significantly after powder-
free, low protein NRL gloves replaced powdered non-sterile gloves in 
this Ontario hospital system. In 2002, Saary et al. (Ref. 23) 
resurveyed the upper-year students and faculty of a dental school in 
Ontario for NRL allergy using the same methods as those used in the 
study performed by Tarlo et al. (Ref. 55). In 1995, the school was 
using powdered NRL gloves in patient care. Following the 1995 survey, 
the school changed to powder-free, low protein NRL gloves. In 2000, the 
incidence of positive prick tests to NRL fell from 10 percent (in 1995) 
to 3 percent and there were significant reductions in the incidence of 
urticaria and immediate pruritus after glove contact reported by the 
dental students.
    Allmers et al. (Ref. 27) reported in 2002 occupational allergy to 
NRL data from the German Professional Association for Health Services 
and Welfare, which covered approximately half of all German hospitals 
and all dental offices. In 1998, Germany banned the use of powdered NRL 
gloves in health care facilities. From 1996 through 2001, the incidence 
of suspected occupational NRL allergy declined steadily as the use of 
powder-free NRL examination gloves and powder-free NRL sterile gloves 
overtook the use of powdered gloves in 1998 and 2000, respectively, in 
German acute care hospitals. The authors concluded that primary 
prevention of occupational NRL allergies could be achieved through 
practical interventions such as decreasing the use of powdered NRL 
gloves. Allmers et al. (Ref. 26) reassessed the effects of the 1998 
German ban on powdered NRL gloves in 2004 and found that between 1996 
and 2002, the incidence of suspected cases of NRL-induced occupational 
allergies reported to the German statutory accident insurance carrier 
decreased by almost 80 percent.
    Charous et al. (Ref. 28) reviewed the scientific literature 
available in 2002 and subsequently recommended using only non-powdered 
sterile NRL gloves or low-protein NRL powdered sterile gloves as 
evaluation of the effect on occupational NRL allergic reactions 
continued, in order to reduce the burden of NRL allergy and its effects 
on health care personnel. Cuming (Ref. 29) also noted that the link 
between glove powder and the occurrence of NRL allergies and 
postoperative

[[Page 15181]]

complications in surgical patients was well supported scientifically 
and described how his four hospital system (not identified) with 
multiple ambulatory care centers and associated medical practices 
successfully eliminated powdered glove use after appropriate alternate 
glove product evaluation.
    Edelstam and colleagues (Ref. 21) described the implementation of a 
powder-free environment in a Stockholm hospital. These authors 
administered symptom questionnaires to hospital staff designed to 
detect symptoms highly suggestive of occupational NRL allergy. They 
found that 8 months after a powder-free policy was fully implemented in 
the hospital there was a significant reduction in reported hand 
itching, eczema, and upper respiratory tract disorders in health care 
workers. The authors also noted that reduced costs associated with 
lower work absence rates may offset higher costs associated with the 
use of powder-free medical gloves.
    In 2005, Korniewicz et al. (Ref. 32) examined whether switching to 
low NRL protein powder-free surgical gloves in the operating room suite 
of a single U.S. university hospital was worth the cost. Surveys prior 
to and 7 to 12 months after the conversion to powder-free surgical 
gloves found that 27 percent fewer health care workers reported skin 
symptoms and 12 percent fewer health care works reported upper 
respiratory symptoms related to NRL exposure. These authors concluded 
that the use of powder-free low protein NRL gloves reduced symptoms and 
resulted in workers compensation cost savings. In addition, because 
fewer different types of gloves were purchased after the conversion to 
non-powdered surgical gloves, a glove cost savings of $10,000 per year 
was estimated for the hospital. In a 2006 report, Filon and Radman 
(Ref. 30) described the results of following 1,040 health care workers 
in Trieste for 3 years before and after the introduction of powder-free 
gloves with low NRL levels. After the introduction of powder-free 
gloves, no new cases of NRL allergy, as diagnosed by skin test 
hypersensitivity to NRL were identified in the followup survey. The 
authors concluded that avoiding unnecessary NRL glove use and using 
non-powdered NRL gloves (and non-NRL gloves for sensitized health care 
workers) could stop the progression of symptoms of NRL allergy and 
avoid new cases of health care provider sensitization to NRL.
    In 2008, Malerich et al. (Ref. 34) studied the effect of 
transitioning from powdered to powder-free NRL gloves on workers' 
compensation claims in a U.S. multihospital system, the Geisinger 
Health System, between 1997 and 2005. They estimated that 52 percent of 
the system work force at that time was occupationally exposed to NRL 
gloves. In 2001, the system transitioned to powder-free NRL gloves. The 
incidence of NRL-related workers' compensation claims decreased 
progressively after 2001, from 62 claims over the 5 year period before 
the change to only 18 claims in the next 4 years. The average annual 
savings in NRL-related compensation claims was estimated to be over 
$30,000. Although the cost of the powder-free NRL gloves resulted in a 
36 percent increase in the cost of gloves, this was partially offset by 
the elimination of the costs of washing powder off the surgical gloves, 
estimated at about $57,000.
    Vandenplas et al. (Ref. 35) reported in 2009 on changes in the 
incidence of NRL-related occupational asthma (OA) claims from health 
care providers submitted to the Workers' Compensation Board of Belgium 
from 1992 through 2004. Definite and probable NRL-related OA incidence 
per 100,000 full-time equivalents for health care workers was 10.9 per 
100,000 in 1991, 19.7 per 100,000 in 1998, and 3.8 per 1,000,000 in 
2003. The overall usage index of NRL-powdered glove use was 80.9 
percent in 1989 and fell to 17.9 percent by 2004. The non-sterile NRL-
powdered glove use index fell from 80.5 percent to 14.4 percent. 
However, the sterile procedure, NRL-powdered glove use index changed 
only from 84.6 percent to 48.9 percent over this 15-year period.
    Although the adverse event risks of glove powder on a variety of 
tissues were well-documented before 1997, investigations to understand 
the pathogenesis of tissue damage caused by glove powder have 
continued. In 1999, Chegini and Rong (Ref. 36) studied the effect of 
glove powder, NRL proteins, and lipopolysaccharide added directly to 
the peritoneal cavity of mice and found that glove powder worsened the 
inflammatory response to tissue injury caused by NRL proteins and 
lipopolysaccharide alone. The study suggested that this interaction 
could contribute to inflammatory or immune reactions and the 
development of adhesions after abdominal surgery. Sj[ouml]sten et al. 
(Ref. 38) published a study in 2000 showing that the intravaginal 
deposition of free glove powder in rabbit vaginas prior to laparotomy 
led to dense pelvic adhesions and even attachment of the Fallopian tube 
to the peritoneal wall after laparotomy with standardized trauma on the 
left Fallopian tube and the ipsilateral peritoneum. The control group 
was not exposed to glove powder and experienced only loose adhesions 
after laparotomy with standardized trauma. The authors recommended 
against the use of powdered gloves during gynecologic surgery.
    In 2001, van den Tol et al. (Ref. 39) found that starch, either 
washed from gloves or pure base starch, when added to the peritoneal 
cavity of rats during laparotomy plus surgical peritoneal trauma, 
caused increased peritoneal adhesion formation. When tumor cells were 
added to the peritoneal cavity at the end of the experimental surgery, 
increased adhesion and growth of the tumor cells occurred in rats who 
also received powder contamination of the peritoneal cavity. These 
authors recommended that powdered gloves no longer be used during 
intra-abdominal surgery on the basis of these results. In 2003, Barbara 
et al. (Ref. 24) found that after guinea pigs were sensitized to NRL 
antigens, with or without added cornstarch powder given by 
intraperitoneal injection, the guinea pigs who received NRL antigens 
mixed with cornstarch had increased antibody production and antigen-
induced constriction of the bronchial tubes when challenged with an 
aerosol of NRL antigens compared to animals who received 
intraperitoneal NRL antigens alone. They concluded that cornstarch 
powder used as a donning agent on NRL gloves can increase sensitization 
to NRL compared to exposure to NRL antigens alone.
    In 2002, Smither et al. (Ref. 41) presented a case report of a 58-
day-old male infant with bilateral scrotal masses due to a foreign body 
reaction to glove powder following a pyloromyotomy performed shortly 
after birth. In 2004, Sj[ouml]sten et al. (Ref. 40) extended their 
prior work on the adverse effects of glove powder in animals to a 
clinical observational study. They found that in patients who underwent 
vaginal examination 1 or 4 days prior to a scheduled hysterectomy with 
either powdered or non-powdered gloves, examination of the removed 
tissues postoperatively detected more starch particles in the cervix 
and uterus of patients examined with powdered gloves. There were no 
differences between the patient groups in the numbers of starch 
particles seen in the distant sites of the Fallopian tubes or the 
peritoneal fluid. In 2 patients examined with powdered gloves, no 
starch particles were found, and 3 patients examined with only powder-
free gloves had a few starch particles in their tissues.

[[Page 15182]]

    Odum et al. (Ref. 43) studied a guinea pig model of paravertebral 
abscess formation. They reported that when slurries of either calcium 
carbonate (CaCO3) or cornstarch were added to guinea pig 
wounds along with Staphylococcus aureus, the wounds with added 
CaCO3 had higher bacterial counts 4 days later than did the 
wounds with added cornstarch, and both had higher bacterial counts than 
the control wounds with only S. aureus inoculated. This study was 
considered by the authors to support an increased risk of wound 
infection after wound exposure to powdered gloves. In addition, Dave et 
al. (Ref. 42) reviewed the literature on glove powder relating to 
dental powdered glove use and noted that cornstarch promoted wound 
infection in reported animal model studies and that cost-effective 
powder-free gloves were available. The authors recommended the use of 
non-powdered gloves in place of powdered gloves. Dwivedi et al. (Ref. 
37) studied both NRL and synthetic latex gloves, both powdered and 
unpowdered in a rat laparotomy model. They found that both non-powdered 
natural rubber latex and powdered surgical gloves resulted in 
peritoneal adhesions. However, powdered NRL gloves further promoted 
increased tissue adhesions, which correlated with elevated serum 
cytokine levels. They suggested that the use of NRL free, powder-free 
gloves would be most effective in decreasing peritoneal adhesion 
formation. In 2010, Suding et al. (Ref. 44) performed another study of 
the effect of cornstarch on experimental model abscess formation. They 
found that the injection of starch into wound sites increased the 
likelihood of methicillin-resistant S. aureus injection abscess 
formation in a rat model.

E. Actions of Other Regulatory Entities and Professional Organizations

    Over the past several years, some domestic health care 
organizations, health care systems, and other nations have banned or 
restricted the use of glove powder because of its deleterious effects 
on the body. Organizations such as the National Institute for 
Occupational Safety and Health (NIOSH), the American Academy of 
Allergy, Asthma, and Immunology (ACAAI), the American College of 
Surgeons (ACS), and the American Nurses Association have all issued 
statements discouraging the use of powdered NRL gloves (Refs. 59 to 
61). In June 1997, the NIOSH of the CDC issued an Alert titled 
``Preventing Allergic Reactions to Natural Rubber Latex in the 
Workplace'' (Ref. 59) in which it recommended that if NRL gloves are 
used in the workplace, they should not be powdered. The ACS issued a 
statement from their Committee on Perioperative Care in 1997 that 
recommended that surgeons should insist on using only non-powdered 
(``powder-free'') surgeons gloves (Ref. 62). The ACAAI issued a 
recommendation (Ref. 60) on the use of NRL gloves in 1997 and stated 
that only non-powdered (``powder-free'') NRL gloves should be purchased 
and used in order to reduce NRL aeroallergen levels and exposure to 
them.
    Moreover, health care systems including the Johns Hopkins Hospital, 
the Cleveland Clinic's network of nine hospitals, and the University of 
Virginia Healthcare System have all restricted or banned the use of 
powdered NRL gloves in their facilities (Refs. 63-64). Finally, the 
international health care systems of Germany and the United Kingdom 
have also independently taken steps against the use of powdered NRL 
gloves due to the dangers of the devices and the hazards they pose in 
the health care setting (Refs. 65-66).
    The Occupational Safety and Health Administration (OSHA) of the 
Department of Labor (DOL) issued a Technical Information Bulletin (TIB 
99-04-12) in 1999 and updated it in 2008 (SHIB 01-28-2008) (Ref. 67) 
describing the risk of sensitization to natural rubber latex products 
used in the workplace. In both of its documents, OSHA recommended that, 
if NRL gloves must be used, they should be non-powdered (``powder-
free'').
    In the 1998 CDC Guideline for Infection Control in Hospital 
Personnel-1998 (Ref. 68), CDC addressed the issues of NRL sensitization 
in the health care workplace and recommended that the use of non-
powdered natural rubber latex gloves would be more efficient than other 
interventions such as trying to wash powder off gloves in reducing NRL 
allergy in the workplace when NRL gloves were retained instead of 
replaced.
    In January 2000, the New Jersey Department of Health and Senior 
Services (DHSS) issued ``Guidelines on the Management of Natural Rubber 
Latex Allergy; Selecting the Right Glove for the Right Task'' (Ref. 69) 
for the health care facility environment. The New Jersey DHSS 
recommended that reduced powder or, preferably, non-powdered NRL gloves 
be used when NRL gloves are selected.
    Allmers and colleagues (Ref. 25) reported that a revised version of 
the technical regulations for dangerous substances (TRGS 540) was 
published in Germany in December 1997 that stated that the use of 
powdered natural rubber latex gloves was not permissible in the 
workplace; only ``powder-free'' NRL gloves could be used.
    In the United Kingdom in 2008, the National Health Service (NHS) 
Plus Occupational Health Clinical Effectiveness Unit, in association 
with the Royal College of Surgeons, issued evidence-based guidelines 
(Ref. 70) on ``the occupational aspects of latex allergy management.'' 
These guidelines include the recommendation that when NHS employers 
determine that a NRL glove is the most suitable choice for use against 
a specific hazard, the NRL glove selected should be a low NRL protein 
glove without glove powder.
    In 2011, the Association of Professionals in Infection Control and 
Epidemiology (APIC) responded to the FDA's request for comments on 
information related to risks and benefits of powdered gloves (Docket 
No. FDA-2011-N-0027). APIC stated (Ref. 71) that it supported the use 
of powder-free surgeon's gloves in health care. It stated also that it 
agreed with the position of the ACS and that of the Association of 
Perioperative Registered Nurses (AORN) that powdered gloves increase 
the risk of sensitization to NRL antigens. APIC also noted that the 
evidence for the role of glove powder in surgical site infection risk 
is limited.

F. Analysis of Medical Device Adverse Events Reported to FDA for 
Medical Gloves

    On its own initiative, FDA evaluated adverse event reports for 
medical gloves that use powder as additional information to help 
determine whether the standard for initiating a ban was met and, if so, 
whether a ban was the appropriate regulatory action to address the 
unreasonable and substantial risk of illness or injury presented by 
powdered gloves.
    We performed a search of our Manufacturer and User Facility Device 
Experience (MAUDE) database to isolate reports through September 30, 
2015, to evaluate the number of adverse events reported for all types 
of medical gloves. A total of 3,780 reports were identified, including 
some that identify inflammation and granulomas. The reports retrieved 
in this query date back to 1992. Charting the reports entered by year 
indicates a bell curve in which the majority of reports were entered in 
1999 with 783 reports. Since 1999, the number of adverse events 
reported for these devices has consistently decreased, and since 2003, 
the number of adverse events reported for these devices has tapered off 
to consistently remain below 100 per year. FDA believes that this 
reduction can be

[[Page 15183]]

attributed to the risks of powdered gloves becoming better known, which 
has led to suitable powder-free alternatives being developed and 
becoming more widely available on the market.
    As discussed in section VIII ``Economic Analysis of Impacts,'' 
market analysis clearly indicates that use of powdered gloves is 
declining, but some individuals and organizations continue to use them 
despite the risks of illness or injury they present. As such, health 
care workers, patients, and other individuals who come in contact with 
glove powder are being exposed to risks unnecessarily, which is one of 
the reasons that FDA decided to initiate this ban.
[GRAPHIC] [TIFF OMITTED] TP22MR16.001

III. The Reasons FDA Initiated the Proceeding; Determination That 
Powdered Gloves Present an Unreasonable and Substantial Risk of Illness

    As described in section 1.D, section 516(a)(1) of the FD&C Act 
authorizes FDA to ban a device intended for human use by regulation if 
it finds, on the basis of all available data and information, that such 
a device ``presents substantial deception or an unreasonable and 
substantial risk of illness or injury'' In this section, we describe 
the reasons we initiated the proceeding to ban powdered gloves, 
including the determination that powdered gloves present an 
unreasonable and substantial risk of illness or injury. In order to 
make this determination, we analyzed both the benefits and the risks 
that these devices pose to those that may come into contact with them, 
comparing those benefits and risks to the benefits and risks posed by 
similar alternative devices.
    As explained in section II, the level and types of risk presented 
by powdered gloves varies depending on the composition and intended use 
of the glove. While some glove types present less risk than others, we 
have concluded that the public's exposure to such risk is substantial 
in relation to the nominal public health benefit derived from the 
continued marketing of these devices. Further, it is FDA's position 
that exposure to these risks is unreasonable in the current market 
where suitable alternatives are readily available that carry none of 
the risks presented by powdered gloves.
    The risk of acute severe airway inflammation due to ADP inhalation 
is a risk presented by all powdered glove types and absorbable powder 
alone and is considered important, material, and significant in 
relation to the minimal potential benefits of greater ease of donning 
and doffing and decreased tackiness. In considering these risks 
relative to the state of the art and alternative non-powdered gloves 
that do not present risks of acute severe airway inflammation, FDA has 
determined that these risks are substantial and unreasonable.
    The risks of inflammatory responses, hypersensitivity reactions, 
and allergic reactions, including asthma, allergic rhinitis, 
conjunctivitis, and dyspnea, are risks presented by all powdered latex 
glove types. FDA has determined that these risks are important, 
material, and significant risks in relation to the minimal potential 
benefits of greater ease of donning and doffing and decreased 
tackiness. In relation to the state of the art of alternative non-
powdered gloves that do not present risks of inflammatory responses, 
hypersensitivity reactions, and allergic reactions, we conclude that 
these risks are substantial and unreasonable.
    The risk of granuloma and adhesion formation is presented to 
patients and health care workers via exposure to internal tissue 
through the use of powdered latex or synthetic surgeon's and patient 
examination gloves. FDA has determined that this risk is important, 
material, and significant in relation to the minimal potential benefits 
of greater ease of donning and doffing and decreased tackiness. In 
relation to the state of the art of

[[Page 15184]]

alternative non-powdered gloves that do not present risk of granuloma 
and adhesion formation, we have concluded that this risk is substantial 
and unreasonable.
    A critical aspect of these devices that FDA considered in coming to 
the decision to propose this ban is their ability to affect persons 
other than the individual who decides to wear or use them. Patients 
often do not know the type of gloves being worn by the health care 
professional treating them, but are still exposed to the potential 
dangers of those gloves. Glove powder's expansive danger zone includes 
persons, including other health care workers, completely unaware or 
unassociated with its employment. In addition, users wear gloves as a 
conventional prophylactic measure to prevent harm, but may be exposed 
to the myriad harms posed by powdered gloves. Although we have noticed 
a progressive reduction in the market share of powdered gloves, some 
individuals and institutions continue to use them. This, in turn, has 
led to continued exposure to the risks presented by powdered gloves.
    In aggregate, the risks posed by these devices include severe 
airway inflammation, hypersensitivity reactions, allergic reactions 
(including asthma), allergic rhinitis, conjunctivitis, dyspnea, as well 
as granuloma and adhesion formation when exposed to internal tissue. 
The state of the art of both surgeon's and patient examination gloves 
includes non-powdered alternatives that provide similar performance as 
the various powdered glove types do: That is, there are many non-
powdered gloves available that have the same level of protection, 
dexterity, and performance. The benefits of these devices appear to 
only include ease of donning and doffing and increased tackiness. We 
have concluded that these benefits are nominal, and that the risks that 
are posed by the continued marketing of powdered gloves outweigh those 
benefits in all instances, especially in light of the current state of 
the art, and the fact that readily available alternatives exist in 
today's market that carry none of these risks. As such, FDA has 
determined that the standard to ban powdered gloves has been met, and 
that it is appropriate to issue this proposal to ban.

IV. FDA's Determination That Labeling, or a Change in Labeling, Cannot 
Correct or Eliminate the Risk

    FDA has determined that powdered surgeon's gloves, powdered patient 
examination gloves, and absorbable powder for lubricating a surgeon's 
glove present an unreasonable and substantial risk of illness or injury 
to individuals, and that no change in labeling could correct the risk 
of illness or injury presented by the continued use of these devices. 
FDA has determined that a ban is the appropriate regulatory approach to 
addressing risks posed by glove powder. No labeling or warnings can 
mitigate the risks posed by these devices.
    As discussed previously, powdered gloves have additional or 
increased risks to health compared to non-powdered gloves related to 
the spread of powder and powder-transported contaminants such as latex 
allergens through aerosols and inhalation or direct or indirect contact 
with wounds, oral, vaginal, rectal tissue, etc. Although labeling can 
raise awareness of these risks, we do not conclude that labeling can 
effectively mitigate these risks because it cannot prohibit the spread 
of glove powder or powder-transported contaminants. In addition, an 
important aspect of these devices is their ability to affect persons 
other than the individual who decides to wear or use them. For example, 
patients often do not know the type of gloves being worn by the health 
care professional treating them, but are still exposed to the potential 
dangers. Similarly, glove powder's ability to aerosolize and carry NRL 
proteins exposes individuals to harm via inhalation or surface contact. 
Glove powder's expansive danger zone includes persons completely 
unaware or unassociated with its employment and without the opportunity 
to consider the devices' labeling. Because of this inherent quality, 
adequate directions for use cannot be written that would ensure the 
safe and effective use of these devices for all persons that might come 
in contact with them.
    In the now withdrawn draft guidance entitled ``Draft Guidance for 
Industry and FDA Staff: Recommended Warning for Surgeon's Gloves and 
Patient Examination Gloves that Use Powder,'' FDA proposed a general 
voluntary warning for powdered glove devices in order to alert users to 
the potential adverse health effects of medical glove powder while FDA 
assessed the benefits and risks of glove powder (Ref. 7) (80 FR 26059). 
In order to facilitate this assessment, concurrent with the issue of 
this draft guidance document, we issued a notice in the Federal 
Register requesting public input on the benefits and risks of powdered 
gloves (76 FR 6684, February 7, 2011; FDA-2011-N-0027). Many of the 
comments we received, in addition to a citizen petition filed in 2011 
(FDA-2011-P-0331-0001), indicated that labeling would not sufficiently 
address the risks posed by glove powder because a warning label would 
not be visible to everyone affected by risks of glove powder.
    Although the use of powdered gloves has declined in recent years, 
the use of these devices has not been eliminated, and patients and 
health care workers continue to be exposed to the risks of glove 
powder. Due to the ability of powder to affect people who would not 
have an opportunity to read warning labels, such a label would be 
ineffective at informing the affected persons of potential risks. In 
addition, potential warning labels would raise awareness of the risks, 
but would not eliminate the risks posed by glove powder. Therefore, 
despite declining use of powdered gloves and previous warning label 
suggestions, FDA has determined no label or warning can mitigate the 
risks posed by these devices.
    Due to the nature of the risks presented by glove powder that are 
posed simply by virtue of the powder being used, we do not conclude 
that additional or new labeling can adequately correct or eliminate the 
risks. As such, in light of all available data and information, FDA has 
determined that it should address the risks posed by glove powder by 
banning its use.

V. FDA's Determination That the Ban Applies to Devices Already in 
Commercial Distribution and Sold to Ultimate Users, and the Reasons for 
This Determination

    FDA has determined that this ban, if finalized, should apply to 
devices already in commercial distribution and devices already sold to 
the ultimate user, as well as to devices that would be sold or 
distributed in the future. (See 21 CFR 895.21(d)(7).) This means that 
powdered gloves currently being used in the marketplace would be 
subject to this ban, and thus adulterated under section 501(g) of the 
FD&C Act and would be subject to enforcement action.
    FDA made this determination because the risks of illness or injury 
to individuals who are currently exposed to these devices is equally 
unreasonable and substantial as it would be for future individuals that 
might be exposed to powdered gloves. Indeed, because suitable 
alternatives already exist in the current marketplace, and because the 
market trends have shown that powder glove use is steadily decreasing, 
it is likely that the remaining users of powder gloves will be able to 
quickly transition to alternatives that are equally effective and carry 
none of the risks associated with powdered gloves. Further, because of 
the steady decrease

[[Page 15185]]

in powdered glove use, it is likely that the greatest number of people 
that might benefit from the ban include those who would be exposed to 
powdered gloves already in distribution. It is our conclusion that this 
group is being unnecessarily exposed to risks that can be eliminated 
through the use of alternative gloves that are readily available. For 
these reasons, FDA has determined that the ban should apply to powdered 
gloves and glove powder already in commercial distribution.

VI. Legal Authority

    This proposed rule, if finalized, would amend Sec. Sec.  878.4460, 
878.4480, 880.6250, 895.102, 895.103, and 895.104. FDA's legal 
authority to modify Sec. Sec.  878.4460, 878.4480, 880.6250, 895.102, 
895.103, and 895.104 arises from the device and general administrative 
provisions of the FD&C Act (21 U.S.C. 352, 360f, 360h, 360i, and 371).

VII. Environmental Impact

    FDA has carefully considered the potential environmental effects of 
this proposed rule and of possible alternative actions. In doing so, we 
focused on the environmental impacts of its action as a result of 
disposal of unused powdered surgeon's gloves, powdered patient 
examination gloves, and absorbable powder for lubricating a surgeon's 
glove that will need to be handled after the rule is finalized.
    The environmental assessment (EA) considered each of the 
alternatives in terms of the need to provide maximum reasonable 
protection of human health without resulting in a significant impact on 
the environment. The EA considered environmental impacts related to 
landfill and incineration of solid waste. The proposed action, if 
finalized, will result in an initial batch disposal of unused powdered 
surgeon's gloves, powdered patient examination gloves, and absorbable 
powder for lubricating a surgeon's glove at user facilities nationwide, 
followed by a rapid decrease in the rate of disposal of these devices, 
as supplies are depleted. The proposed action does not change the 
ultimate disposition of these devices but expedites their rate of 
disposal and ceases future production. Overall, given the limited 
number of powdered surgeon's gloves, powdered patient examination 
gloves, and absorbable powder for lubricating a surgeon's glove, 
currently in commercial distribution, the proposed action is expected 
to have no significant impact on landfill and solid waste facilities 
and the environment in affected communities.
    The Agency has concluded that the proposed rule will not have a 
significant impact on the human environment, and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact (FONSI) and the evidence supporting that finding, contained in 
an EA prepared under 21 CFR 25.40, may be seen in the Division of 
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday (Ref. 72). FDA invites comments and submission of data 
concerning the EA and FONSI.

VIII. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the proposed rule. We believe that this 
proposed rule is not a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because this rule imposes no new burdens, we propose to 
certify that the final rule would not have a significant economic 
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.

B. Summary

    The proposed rule, if finalized, would prohibit marketing of 
powdered surgeon's gloves, powdered patient examination gloves, and 
absorbable powder for lubricating surgeon's gloves. The rule does not 
cover or include powdered radiographic gloves. In the past, powdering 
gloves was a popular method to make the gloves easier to put on and 
remove. However, recent studies indicate that these powders pose an 
unnecessary risk to medical workers (Ref. 73 and 74). Their results 
note that these powders carry the latex material on latex gloves. As a 
result, medical workers who are sensitive to latex are occasionally 
exposed to enough latex to develop an allergy.
    Adopting the proposed rule is expected to provide a positive net 
benefit (estimated benefits minus estimated costs) to society. Banning 
powdered glove products is not expected to impose any costs to society 
because improvements to non-powdered gloves have made these products as 
affordable and easy to put on as powdered gloves. The ban is expected 
to reduce the adverse events associated with using powdered gloves. 
Total annual benefits are estimated to range between $26.6 million and 
$29.3 million.
    The Economic Analysis of Impacts of the proposed rule performed in 
accordance with Executive Order 12866, Executive Order 13563, the 
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act is 
available at https://www.regulations.gov under the docket number(s) 
(FDA-2015-N-5017) for this proposed rule and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 
75). We invite comments on this analysis.

IX. Proposed Effective Date

    FDA is proposing that any final rule based on this proposed rule 
become effective 30 days after the date of its publication in the 
Federal Register. FDA proposes that manufacturers must not market any 
new units of affected devices after the effective date of any final 
rule based on this proposal. FDA requests comment on the proposed 
effective date for this proposed rule. Once this rule is finalized, all 
powdered surgeon's gloves, powdered patient examination gloves, and 
absorbable powder for lubricating a surgeon's gloves must be removed 
from the market by the effective date provided in the final rule or the 
device will be deemed adulterated. Section 501(g) of the FD&C

[[Page 15186]]

Act deems a device to be adulterated if it is a banned device.

X. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

XI. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive order requires Agencies to ``construe . . . a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' Federal law includes an express preemption 
provision that preempts certain State requirements ``different from or 
in addition to'' certain Federal requirements applicable to devices (21 
U.S.C. 360k; See Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); Riegel 
v. Medtronic, Inc., 552 U.S. 312 (2008)). This proposed rule, if 
finalized, would create a requirement under 21 U.S.C. 360k that bans 
Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and 
Absorbable Powder for Lubricating a Surgeon's Glove.

XII. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. ``Guidance for Industry and FDA Staff: Medical Glove Guidance 
Manual,'' January 22, 2008, available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM428191.pdf.
2. Association for Testing and Materials, ``ASTM D6124 Standard Test 
Method for Residual Powder on Medical Gloves,'' 2011, available at: 
https://www.astm.org/Standards/D6124.htm.
3. Ellis, H., ``The Hazards of Surgical Glove Dusting Powders,'' 
Surgery, Gynecology and Obstetrics, 171(6):521-527, 1990.
4. Ellis, H., ``Pathological Changes Produced by Surgical Dusting 
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5. Food and Drug Administration, Stratmeyer, M., T. Cunningham, A. 
Lowery, et al., Medical Glove Powder Report. 1997, available at: 
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6. ``Draft Guidance for Industry and FDA: Medical Glove Guidance 
Manual,'' issued July 30, 1999; withdrawn January 22, 2008.
7. ``Draft Guidance for Industry and FDA Staff: Recommended Warning 
for Surgeon's Gloves and Patient Examination Gloves that Use 
Powder,'' issued February 7, 2011; withdrawn April 27, 2015.
8. Ahmed, S.M., T.C. Aw, and A. Adisesh, ``Toxicological and 
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Reviews, 23(2):123-134, 2004.
9. Fisher, M.D., V.R. Reddy, F.M. Williams, et al., ``Biomechanical 
Performance of Powder-Free Examination Gloves,'' The Journal of 
Emergency Medicine, 17(6):1011-1018, 1999, available at: https://www.sciencedirect.com/science/article/pii/S073646799900133X.
10. Kerr, L.N., M.P. Chaput, L.D. Cash, et al., ``Assessment of the 
Durability of Medical Examination Gloves,'' Journal of Occupational 
and Environmental Hygiene, 1(9):607-612, 2004.
11. Korniewicz, D.M., M. El-Masri, J.M. Broyles, et al., 
``Performance of Latex and Nonlatex Medical Examination Gloves 
During Simulated Use,'' American Journal of Infection Control, 
30(2):133-138, 2002, available at: https://www.sciencedirect.com/science/article/pii/S0196655302751626.
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Control, 27(5):405-410, 1999, available at: https://www.sciencedirect.com/science/article/pii/S0196655399700064.
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Approaches,'' Methods, 27(1):69-76, 2002, available at: https://www.sciencedirect.com/science/article/pii/S1046202302000543.
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20. Charous, B.L., P.J. Schuenemann, and M.C. Swanson, ``Passive 
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of Allergy, Asthma & Immunology, 85(4):285-290, 2000, available at: 
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21. Edelstam, G., L. Arvanius, and G. Karlsson, ``Glove Powder in 
the Hospital Environment--Consequences for Healthcare Workers,'' 
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75(4):267-271, 2002, availabe at: https://link.springer.com/article/10.1007%2Fs00420-001-0296-y.
22. Kujala, V., H. Alenius, T. Palosuo, et al., ``Extractable Latex 
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23. Saary, M.J., A. Kanani, H. Alghadeer, et al., ``Changes in Rates 
of Natural Rubber Latex Sensitivity Among Dental School Students and 
Staff Members After Changes in Latex Gloves,'' Journal of Allergy 
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24. Barbara, J., M.C. Santais, D.A. Levy, et al., ``Immunoadjuvant 
Properties of Glove Cornstarch Powder in Latex-Induced 
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25. Allmers, H., R. Brehler, Z. Chen, et al., ``Reduction of Latex 
Aeroallergens and Latex-Specific IgE Antibodies in Sensitized 
Workers After Removal of Powdered Natural Rubber Latex Gloves in a 
Hospital,'' Journal of Allergy and Clinical Immunology, 102(5):841-
846, 1998.
26. Allmers, H., J. Schmengler, and S.M. John, ``Decreasing 
Incidence of Occupational Contact Urticaria Caused by Natural Rubber 
Latex Allergy in German Health Care Workers,'' Journal of Allergy 
and Clinical Immunology, 114(2):347-351, 2004, available at: https://www.sciencedirect.com/science/article/pii/S0091674904015684.
27. Allmers, H., J. Schmengler, and C. Skudlik, ``Primary Prevention 
of Natural

[[Page 15187]]

Rubber Latex Allergy in the German Health Care System Through 
Education and Intervention,'' Journal of Allergy and Clinical 
Immunology, 110(2):318-323, 2002, available at: https://www.sciencedirect.com/science/article/pii/S0091674902000970.
28. Charous, B.L., C. Blanco, S. Tarlo, et al., ``Natural Rubber 
Latex Allergy After 12 Years: Recommendations and Perspectives,'' 
Journal of Allergy and Clinical Immunology, 109(1):31-34, 2002.
29. Cuming, R.G., ``Reducing the Hazards of Exposure to Cornstarch 
Glove Powder,'' AORN Journal, 76(2):288-295, 2002.
30. Filon, F.L. and G. Radman, ``Latex Allergy: A Follow Up Study of 
1040 Healthcare Workers,'' Journal of Occupational and Environmental 
Medicine, 63(2):121-125, 2006, available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2078060/.
31. Jackson, E.M., J.A. Arnette, M.L. Martin, et al., ``A Global 
Inventory of Hospitals Using Powder-Free Gloves: A Search for 
Principled Medical Leadership,'' Journal of Emergency Medicine, 
18(2):241-246, 2000, available at: https://www.sciencedirect.com/science/article/pii/S0736467999002024.
32. Korniewicz, D.M., N. Chookaew, J. Brown, et al., ``Impact of 
Converting to Powder-Free Gloves. Decreasing the Symptoms of Latex 
Exposure in Operating Room Personnel,'' American Association of 
Occupational Health Nurses Journal, 53(3):111-116, 2005.
33. Liss, G.M. and S.M. Tarlo, ``Natural Rubber Latex-Related 
Occupational Asthma: Association With Interventions and Glove 
Changes Over Time,'' American Journal of Industrial Medicine, 
40(4):347-353, 2001.
34. Malerich, P.G., M.L. Wilson, and C.M. Mowad, ``The Effect of a 
Transition to Powder-Free Latex Gloves on Workers' Compensation 
Claims for Latex-Related Illness,'' Dermatitis, 19(6):316-318, 2008.
35. Vandenplas, O., A. Larbanois, F. Vanassche, et al., ``Latex-
Induced Occupational Asthma: Time Trend in Incidence and 
Relationship With Hospital Glove Policies,'' Allergy, 64(3):415-420, 
2009.
36. Chegini, N. and H. Rong, ``Postoperative Exposure to Glove 
Powders Modulates Production of Peritoneal Eicosanoids During 
Peritoneal Wound Healing,'' European Journal of Surgery, 165(7):698-
704, 1999.
37. Dwivedi, A.J., N.K. Kuwajerwala, Y.J. Silva, et al., ``Effects 
of Surgical Gloves on Postoperative Peritoneal Adhesions and 
Cytokine Expression in a Rat Model,'' American Journal of Surgery, 
188(5):491-494, 2004, available at: https://www.sciencedirect.com/science/article/pii/S0002961004003526.
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List of Subjects

21 CFR Parts 878 and 880

    Medical devices.

21 CFR Part 895

    Administrative practice and procedure, Labeling, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 878, 880, and 895 be amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Amend Sec.  878.4460 by revising the heading and paragraph (a) to 
read as follows:


Sec.  878.4460  Non-powdered surgeon's glove.

    (a) Identification. A non-powdered surgeon's glove is a device made 
of natural rubber latex or synthetic latex, intended to be worn by 
operating room personnel to protect a surgical wound from 
contamination. A non-powdered surgeon's glove does not incorporate 
powder for purposes other than manufacturing. The final finished glove 
includes only residual powder from manufacturing.
* * * * *


Sec.  878.4480  [Removed]

0
3. Remove Sec.  878.4480.

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
4. The authority citation for 21 CFR part 880 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
5. Amend Sec.  880.6250 by revising the heading and paragraph (a) to 
read as follows:


Sec.  880.6250  Non-powdered patient examination glove.

    (a) Identification. A non-powdered patient examination glove is a 
disposable device made of either natural rubber latex or synthetic 
latex, intended for medical purposes, that is worn on the examiner's 
hand or finger to prevent contamination between patient and examiner. A 
non-powdered patient examination glove does not incorporate powder for 
purposes other than manufacturing. The final finished glove includes 
only residual powder from manufacturing.
* * * * *

PART 895--BANNED DEVICES

0
6. The authority citation for 21 CFR part 895 continues to read as 
follows:

    Authority: 21 U.S.C. 352, 360f, 360h, 360i, 371.

0
7. Add Sec.  895.102 to subpart B to read as follows:


Sec.  895.102  Powdered surgeon's glove.

    A powdered surgeon's glove is a device made of natural rubber latex 
or synthetic latex, intended to be worn by operating room personnel to 
protect a surgical wound from contamination. A powdered surgeon's glove 
incorporates powder for purposes other than manufacturing.
0
8. Add Sec.  895.103 to subpart B to read as follows:


Sec.  895.103  Powdered patient examination glove.

    A powdered patient examination glove is a disposable device made of 
natural rubber latex or synthetic latex, intended for medical purposes, 
that is worn on the examiner's hand or finger to prevent contamination 
between patient and examiner. A powdered patient examination glove 
incorporates powder for purposes other than manufacturing.
0
9. Add Sec.  895.104 to subpart B to read as follows:


Sec.  895.104  Absorbable powder for lubricating a surgeon's glove.

    Absorbable powder for lubricating a surgeon's glove is a powder 
made from cornstarch that meets the specifications for absorbable 
powder in the United States Pharmacopeia (U.S.P.) and that is intended 
to be used to lubricate the surgeon's hand before putting on a 
surgeon's glove. The device is absorbable through biological 
degradation.

    Dated: March 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06360 Filed 3-21-16; 8:45 am]
BILLING CODE 4164-01-P