Banned Devices; Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove, 91722-91731 [2016-30382]

Agencies

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

[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Rules and Regulations]
[Pages 91722-91731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30382]


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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; Powdered Surgeon's Gloves, Powdered Patient 
Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's 
Glove

AGENCY: Food and Drug Administration, HHS.

ACTION: Final 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 banning these devices.

DATES: This rule is effective on January 18, 2017.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the

[[Page 91723]]

heading of this final rule 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: Michael J. Ryan, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993, 301-796-
6283, email: michael.ryan@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
    C. General Overview of Final Rule
    D. Clarifying Changes to the Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA's Responses
    A. Introduction
    B. Description of General Comments and FDA Response
    C. Description of Comments That Oppose the Regulation and FDA 
Response
    D. Description of Comments on Scope of Ban and FDA Response
    E. Description of Other Specific Comments and FDA Response
V. Effective Date
VI. Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. References

I. Executive Summary

A. Purpose and Coverage of the Final Rule

    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. However, the use of powder on medical 
gloves presents numerous risks to patients and health care workers, 
including inflammation, granulomas, and respiratory allergic reactions.
    A thorough review of all currently available information supports 
FDA's conclusion that powdered surgeon's gloves, powdered patient 
examination gloves, and absorbable powder for lubricating a surgeon's 
glove should be banned. FDA has concluded that the risks posed by 
powdered gloves, including health care worker and patient sensitization 
to natural rubber latex (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, are important, material, and significant in relation to the 
benefit to public health from their continued marketing. FDA has 
carefully evaluated the risks and benefits of powdered gloves and the 
risks and benefits of the state of the art, which includes viable non-
powdered alternatives that do not carry any of the risks associated 
with glove powder, and has determined that the risk of illness or 
injury posed by powdered gloves is unreasonable and substantial. 
Further, 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.
    This rule applies to powdered patient examination gloves, powdered 
surgeon's gloves, and absorbable powder for lubricating a surgeon's 
glove. This includes all powdered medical gloves except powdered 
radiographic protection gloves. Because we are not aware of any 
powdered radiographic protection gloves that are currently on the 
market, FDA lacks the evidence to determine whether the banning 
standard would be met for this particular device. The ban does 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 (mg) 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. 
The ban also does 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.

B. Summary of the Major Provisions of the Final Rule

    In this final rule, FDA is banning the following devices: (1) 
Powdered surgeon's gloves, (2) powdered patient examination gloves, and 
(3) absorbable powder for lubricating a surgeon's glove. Because the 
classification regulations for these device types do not distinguish 
between powdered and non-powdered versions, FDA is amending the 
descriptions of these devices in the regulations to specify that the 
regulations for patient examination and surgeon's gloves will apply 
only to non-powdered gloves while the powdered version of each type of 
glove will be added to the listing of banned devices in the 
regulations.
    Many comments requested that FDA revise the scope of the ban to 
include all NRL gloves. Many comments from industry requested that the 
proposed effective date be extended beyond 30 days after the date of 
publication of the final rule. Of the comments that do not support the 
ban, commenters noted the need for powdered gloves to aid in donning 
gloves and tactile sense and the reduced risks associated with current 
powdered gloves that have less powder. The remaining comments are not 
clearly in support or opposition to the proposal.

C. Legal Authority

    Powdered surgeon's gloves, powdered patient examination gloves, and 
absorbable powder for lubricating a surgeon's glove are defined as 
devices under section 201(h) of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 321(h)). Section 516 of the FD&C Act (21 
U.S.C. 360f) authorizes FDA to ban a device if it finds, on the basis 
of all available data and information, that the device presents 
substantial deception or unreasonable and substantial risks of illness 
or injury, which cannot be corrected by labeling or a change in 
labeling. This rule amends 21 CFR 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).

[[Page 91724]]

D. Costs and Benefits

    The final 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, but is 
expected to reduce the number of adverse events associated with using 
powdered gloves. The primary public health benefit from adoption of the 
rule would be the value of the reduction in adverse events associated 
with using powdered gloves. The Agency estimates maximum total annual 
net benefits to range between $26.8 million and $31.8 million.

II. Background

A. Need for the Regulation/History of the Rulemaking

    On March 22, 2016, FDA issued a proposed rule to ban powdered 
surgeon's gloves, powdered patient examination gloves, and absorbable 
powder for lubricating a surgeon's glove (81 FR 15173). 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.'' For a more 
detailed discussion of the banning standard, we refer you to the 
preamble of the proposed rule. FDA issued the proposed regulation 
because it 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.
    The preamble to the proposed rule describes the history of powdered 
gloves and the citizen petitions received by the Agency that request a 
ban on powdered gloves. We refer readers to that preamble for 
information about the development of the proposed rule. The level and 
types of risk presented by powdered gloves varies depending on the 
composition and intended use of the glove. In aggregate, the risks of 
powdered gloves 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. We refer readers to the preamble of 
the proposed rule for details on the level and types of risks presented 
by powdered gloves. The benefits of powdered gloves appear to only 
include greater ease of donning and doffing, decreased tackiness, and a 
degree of added comfort, which FDA believes are nominal when compared 
to the risks posed by these devices.
    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. Thus, based on a careful 
evaluation of the risks and benefits of powdered gloves and the risks 
and benefits of the current state of the art, which includes readily 
available alternatives that carry none of the risks posed by powdered 
gloves, FDA has determined that the standard to ban powdered gloves has 
been met, and that it is appropriate to issue this ban.
    Finally, as discussed in the proposed rule, FDA also determined the 
ban 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 adulterated under section 501(g) of 
the FD&C Act (21 U.S.C. 351(g)), and thus subject to enforcement 
action.

B. Summary of Comments to the Proposed Rule

    The Agency requested public comments on the proposed rule, and the 
comment period closed on June 20, 2016. The Agency received 
approximately 100 comment letters on the proposed rule by the close of 
the comment period, each containing one or more comments on one or more 
issues. We received comments from a cross-section of patients and 
consumers, medical professionals, device manufacturers, and 
professional and trade associations. A majority of the comments 
supported the objectives of the rule in whole or in part, while a 
minority of the comments opposed the objectives of the rule. Some 
comments suggested changes to specific elements of the proposed rule or 
requested clarification of matters discussed in the proposed rule. See 
Section IV for the description of comments on the proposed rule and 
FDA's responses.

C. General Overview of the Final Rule

    FDA published a proposed rule to ban powdered surgeon's gloves, 
powdered patient examination gloves, and absorbable powder for 
lubricating a surgeon's glove, because FDA determined that these 
devices 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 (81 FR 15173).
    In this final rule, FDA is banning 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 amending the 
descriptions of these devices in the regulations to specify that the 
regulations for surgeon's gloves (21 CFR 878.4460) and patient 
examination gloves (21 CFR 880.6250) will apply only to non-powdered 
gloves while the powdered version of each type of glove will be added 
to 21 CFR part 895, subpart B--Listing of Banned Devices.

D. Clarifying Changes to the Rule

    While FDA believes that the preamble to the proposed rule was clear 
that the proposed ban would apply to all powdered surgeon's gloves and 
all powdered patient examination gloves, in reviewing the terminology 
used in the proposed additions to 21 CFR part 895, FDA determined that 
term ``synthetic latex'' would not cover every type of non-NRL material 
that is used to manufacture powdered gloves. It was not FDA's intent to 
limit the ban to only powdered NRL and powdered synthetic latex gloves, 
and we believe that this intent was clear from the content of the 
preamble to the proposed rule, which stated that the ban ``would apply 
to all powdered gloves except powdered radiographic protection 
gloves.'' As such, FDA has now revised the identification in this final 
rule to clarify that the ban applies to all powdered surgeon's gloves 
and powdered patient examination gloves without reference to the type 
of material from which they are made. Additionally, the identification 
of non-powdered surgeon's gloves and non-powdered patient examination 
gloves is also being revised to remove reference to material.

III. Legal Authority

    Powdered surgeon's gloves, powdered patient examination gloves, and 
absorbable powder for lubricating a surgeon's glove are defined as 
medical devices under section 201(h) of the FD&C Act (21 U.S.C. 321). 
Section 516 of the FD&C Act (21 U.S.C. 360f) authorizes FDA to ban a 
device if it finds, on the basis of all available data and information, 
that the device

[[Page 91725]]

presents substantial deception or unreasonable and substantial risks of 
illness or injury, which cannot be corrected by labeling or a change in 
labeling. This rule amends 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).

IV. Comments on the Proposed Rule and FDA's Responses

A. Introduction

    We received approximately 100 comment letters on the proposed rule 
by the close of the comment period, each containing one or more 
comments on one or more issues. We received comments from a cross-
section of patients and consumers, medical professionals, device 
manufacturers, and professional and trade associations. A majority of 
the comments supported the objectives of the rule in whole or in part, 
while a minority of the comments opposed the objectives of the rule. 
Some comments suggested changes to specific elements of the proposed 
rule or requested clarification of matters discussed in the proposed 
rule.
    We describe and respond to the comments in section IV.B through E. 
We have numbered each comment to help distinguish between different 
comments. We have grouped similar comments together under the same 
number, and, in some cases, we have separated different issues 
discussed in the same comment and designated them as distinct comments 
for purposes of our responses. The number assigned to each comment or 
comment topic is purely for organizational purposes and does not 
signify the comment's value or importance or the order in which 
comments were received.

B. Description of General Comments and FDA Response

    Many comments made general remarks supporting or opposing the 
proposed rule without focusing on a particular proposed provision. In 
the following paragraphs, we discuss and respond to such general 
comments.
    (Comment 1) Many comments support the proposed ban on powdered 
patient examination gloves and powdered surgeon's gloves. These 
comments from individual consumers, health care professionals, 
academia, and industry highlight several risks of the continued use of 
powdered gloves, including, among others, allergic reactions, post-
operative adhesions, and delayed wound healing.
    (Response 1) FDA agrees with these comments. After further review 
of all available information and the comments submitted to the proposed 
rule, FDA has concluded that the public's exposure to the risks of 
powdered gloves is unreasonable and substantial in relation to the 
nominal public health benefit derived from the continued marketing of 
these devices, especially when considering the benefits and risks posed 
by readily available alternative devices. Therefore, FDA has determined 
that the standard for a ban on these devices has been met.

C. Description of Comments That Oppose the Regulation and FDA Response

    FDA received some comments that oppose the proposed ban on powdered 
patient examination gloves and powdered surgeon's gloves for various 
reasons. We address each of these reasons for opposition in this 
section. After reviewing these comments, FDA has determined that the 
standard to ban powdered gloves has been met, and that it is 
appropriate to issue this ban. We are finalizing the ban with only 
clarifying changes.
    (Comment 2) Comments oppose the proposed ban on powdered patient 
examination gloves and powdered surgeon's gloves because of difficulty 
donning or doffing non-powdered gloves. Two commenters specifically 
discuss hyperhidrosis with claims that it can add to the difficulty 
donning and doffing non-powdered gloves. One commenter has asserted 
that double-gloving is more difficult when using non-powdered gloves.
    (Response 2) As described in the preamble of the proposed rule, we 
have concluded that the benefit of ease of donning or doffing powdered 
gloves is generally nominal (Ref. 3) in comparison to the risks posed 
by the continued marketing of powdered gloves, which, among others, 
include severe airway inflammation, hypersensitivity reactions, and 
allergic reactions (including asthma). Also, as noted in the proposed 
rule, 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. 
3). Thus, FDA has considered ease of donning and doffing as a benefit 
as it applies within the banning standard, and has determined that the 
standard is met.
    (Comment 3) Comments oppose the proposed ban on powdered patient 
examination gloves and powdered surgeon's gloves because of difficulty 
donning non-powdered gloves, leading to greater propensity of non-
powdered gloves to tear. Some of these comments express concern that 
the reduced ability to separate the opening of a non-powdered glove or 
the greater propensity of non-powdered gloves to tear could potentially 
lead to a higher degree of contamination and post-procedure infections.
    (Response 3) FDA disagrees with the assertion that non-powdered 
gloves have a higher propensity to tear and thus disagrees that use of 
non-powdered gloves presents a greater risk of contamination, post-
procedure infections, or exposure of the user to blood. FDA does not 
believe there is compelling evidence to support the assertion that non-
powdered gloves have a higher propensity to tear. Korniewicz, et al., 
determined that the presence of powder did not affect the durability of 
gloves or enhance glove donning (Ref. 4). Although Kerr, et al., 
identified a statistically significant difference in the durability of 
non-powdered vinyl gloves compared to powdered vinyl gloves, this 
difference may be attributed to glove type, manufacturer, and the 
fingernail length of users rather than the presence or absence of 
powder (Ref. 5). This study also found that vinyl gloves in general are 
less durable and have a greater propensity to tear compared to nitrile, 
neoprene, and latex gloves. Furthermore, as discussed in the response 
to comment 4, several studies have found that alternatives to non-
powdered NRL gloves, such as nitrile and neoprene gloves, offer the 
same level of protection against contamination and exposure to blood as 
powdered NRL gloves (Refs. 5, 6, 7, 8, 9, and 10). Therefore, FDA has 
determined that suitable alternatives to powdered gloves are readily 
available in the marketplace.
    (Comment 4) Commenters oppose the proposed ban on powdered patient 
examination gloves and powdered surgeon's gloves because the fit of 
powdered gloves is more comfortable than non-powdered gloves. Some of 
these comments assert that the reduced fit of non-powdered gloves 
inhibits the tactile sensation necessary to perform medical procedures.
    (Response 4) FDA disagrees with the assertion that non-powdered 
gloves inhibit the tactile sensation necessary to perform medical 
procedures. The ban does not include non-powdered NRL gloves, which 
offer the same

[[Page 91726]]

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 (Refs. 5, 6, 7, 8, 9, and 10). Furthermore, the numerous risks 
posed by the continued marketing of powdered gloves outweigh the 
benefit of whatever additional level of comfort is provided from using 
powdered gloves instead of the non-powdered alternatives that carry 
none of these risks.
    (Comment 5) Some comments oppose the proposed ban on powdered 
patient examination gloves and powdered surgeon's gloves, citing a lack 
of scientific evidence that gloves with reduced powder content, as 
those in use today, have the same risks as previously used gloves that 
had higher powder content.
    (Response 5) FDA agrees that the maximum residual level of powder 
on powdered gloves is less than earlier types of powdered gloves. 
Historically, powdered medical gloves contained powder levels ranging 
from 50 to over 400 mg of powder per glove. Effective in 2002, the ASTM 
International recommended limits on powder levels is 15 mg per square 
decimeter for surgical gloves (ASTM D3577-2001) (Ref. 11) and 10 mg per 
square decimeter for patient examination gloves (ASTM D3578) (Ref. 12). 
As a result, FDA believes that gloves in use after 2002 follow these 
recommended limits and generally have lower powder content than earlier 
types of powdered gloves. Even so, several studies indicate that gloves 
with reduced powder levels continue to present unreasonable and 
substantial risks to patients and health care workers. For instance, a 
study conducted on the incidence of skin reactions for Greek 
endodontists from 2006 to 2012 found that glove powder accounted for 
the majority of skin reactions, and the replacement of powdered NRL 
gloves with non-powdered gloves resolved the majority of the adverse 
reactions (Ref. 13). Similarly, the risks of powdered gloves persist in 
non-clinical studies using gloves with reduced powder content, as 
demonstrated by the 2013 finding that surgeries performed with powdered 
gloves increased the number, density, and fibrotic properties of 
peritoneal adhesions in rats compared with surgeries performed with 
non-powdered gloves (Ref. 14). Also, the reduction in cases of NRL-
induced occupational contact urticaria coincided with French hospitals 
transitioning to non-powdered gloves after 2004-2005 (Ref. 13). 
Finally, FDA is not aware of any report in the literature that supports 
the assertion that currently marketed powdered gloves with lower powder 
content reduce the risks presented by powdered gloves (Ref. 15). In 
summary, FDA concludes that the risks of powder continue to be 
unreasonable and substantial for currently marketed powdered gloves 
despite lower powder content than previous generations of powdered 
gloves.
    (Comment 6) Two comments oppose the proposed ban on powdered 
patient examination gloves and powdered surgeon's gloves, because the 
commenters believe a warning on the risks of powdered gloves is 
sufficient to mitigate the risks posed by these devices.
    (Response 6) As described in Section IV of the proposed rule, FDA 
has determined that no change in labeling could correct the risk of 
illness or injury presented by the continued use of these devices. 
Powdered gloves have additional or increased risks to health compared 
to non-powdered gloves related to the spread of powder, and the fact 
that powder-transported contaminants such as NRL allergens can become 
aerosolized. Exposure to powder or latex allergens presents significant 
risks to health care workers and patients when inhaled or when exposed 
to internal tissue during oral, vaginal, gynecological, and rectal 
exams. Although labeling can raise awareness of these risks, we 
conclude that labeling cannot 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. Thus, some of the risks posed 
by glove powder can impact 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 or warnings cannot be written that would provide 
reasonable assurance of the safe and effective use of these devices for 
all persons that might come in contact with them.
    Due to the ability of powder to affect people who would not have an 
opportunity to read warning labels, and because potential warning 
labels would raise awareness of the risks, but would not eliminate the 
risks posed by glove powder, FDA has determined no label or warning can 
correct the risks posed by these devices.
    (Comment 7) One comment opposes the proposed ban on powdered 
patient examination gloves and powdered surgeon's gloves, because the 
solvent used to remove powder during the manufacture of non-powdered 
gloves may cause adverse reactions to the glove user.
    (Response 7) FDA is not aware of any report in the literature that 
supports the assertion of widespread adverse reactions to solvent used 
in the manufacturing process. Non-powdered patient examination and 
surgeon's gloves require premarket notification (510(k)) submissions 
prior to marketing. During the review of these submissions, FDA 
evaluates the final finished glove, including manufacturing solvents 
that are present on the final glove. FDA recommends that manufacturers 
conduct and submit skin irritation and dermal sensitization studies in 
these submissions to evaluate potential issues with components, 
including manufacturing solvents (Ref. 1). Although individual 
hypersensitivity reactions to different materials may occur, FDA has 
been unable to find evidence in the literature of hypersensitivity to 
typical glove manufacturing materials other than glove powder or NRL. 
However, Palosuo, et al., reports that the use of hand sanitizers 
containing isopropyl alcohol prior to donning gloves could cause 
dermatitis reaction if the gloves are donned before the alcohol dries 
(Ref. 16). The occurrence of this reaction is unrelated to the 
manufacture of non-powdered gloves and unrelated to the use of non-
powdered gloves as an alternative to powdered gloves. Given the lack of 
evidence of adverse reactions to solvents used in the manufacturing of 
non-powdered gloves, and the established evidence demonstrating the 
risks of powdered glove use, FDA continues to believe that powdered 
gloves and glove powder meet the banning standard.
    (Comment 8) Several comments oppose the proposed ban on powdered 
patient examination gloves and powdered surgeon's gloves due to the 
expectation that users will ultimately have to pay more for medical 
gloves once the ban is finalized, because the cost of non-powdered 
gloves is currently higher than the cost of powdered gloves.
    (Response 8) We do not find any evidence to support the claims that

[[Page 91727]]

current prices of non-powdered gloves are significantly higher than 
powdered gloves. As we stated in the preliminary regulatory impact 
analysis (PRIA), extensive searches of glove distributor pricing 
indicate that non-powdered gloves have become as affordable as powdered 
gloves. Our searches also revealed that the market is saturated with 
alternatives to powdered gloves, resulting in downward pressure on the 
prices of non-powdered gloves. In addition, the share of powdered 
medical gloves sales has been declining since at least 2000 while total 
sales of all disposable medical gloves have increased (Ref. 17). We 
would not expect this trend to be occurring without regulatory action 
if users of disposable medical gloves faced significantly higher prices 
for switching to non-powdered gloves. We therefore do not find it 
necessary to update our analysis based on these comments.
    (Comment 9) We received one comment that disagrees with our 
determination that the availability of examination and surgical gloves 
would not be reduced.
    (Response 9) We do not find any evidence to support these claims. 
As we stated in the PRIA, research shows only 7 percent of total sales 
of examination and surgical gloves to medical workers were projected to 
be from powdered gloves in 2010 (Ref. 17). Global Industry Analysts 
(GIA) projected the share of powdered disposable medical gloves sales 
to decrease to 2 percent in 2015, while total sales of all disposable 
medical gloves continue to increase (Ref. 17). We would not expect this 
trend to be occurring without regulatory action if there were a 
reduction in the availability of disposable examination and surgical 
gloves. We therefore do not find it necessary to update our analysis 
based on these comments.
    (Comment 10) Commenters suggest there would be a loss in consumer 
utility due to the preference some medical workers may have for 
powdered gloves due to comfort and ease of use.
    (Response 10) We stated in the PRIA that the remaining 7 percent 
continuing to use these powdered gloves may experience utility loss 
from the removal of powdered gloves from the market (Ref. 17). The 
potential loss in consumer utility would be due to the perceived loss 
in comfort from powdered gloves users switching to non-powdered gloves. 
However, as the GIA report shows, there has been a downward trend in 
total sales of powdered gloves since at least the year 2000 while total 
sales of all disposable medical gloves has increased (Ref. 17). We 
would not expect this trend to be occurring without regulatory action 
if the loss in consumer utility to current medical workers were 
substantial. Korniewicz et al. reported no loss in consumer 
satisfaction in a sample of operating room staff switching to non-
powdered surgical gloves (Ref. 4). We have not estimated this potential 
burden, but the evidence described here suggests that any burden would 
not be substantial. Further, even having considered that some degree of 
consumer comfort may be lost by banning powdered gloves, FDA continues 
to believe that this benefit is considerably outweighed by the numerous 
risks posed by powdered gloves.
    (Comment 11) One comment opposes the proposed ban on powdered 
patient examination gloves and powdered surgeon's gloves, because the 
risks identified for powdered gloves are due to contaminants, such as 
pesticides and herbicides, in the powder that would not be present if 
the powder were manufactured in the United States.
    (Response 11) FDA disagrees with the assertion that contaminated 
powder is the source of the risks identified for powdered gloves. FDA's 
proposal to ban powdered gloves and glove powder is based on various 
studies on the risks of powdered gloves due to the properties of the 
powder itself. Powdered gloves have additional or increased risks to 
health compared to non-powdered gloves. For example, powder on NRL 
gloves can aerosolize latex allergens, resulting in sensitization to 
latex and allergic reactions. Latex sensitization and allergic 
reactions are unrelated to any potential presence of manufacturing 
contaminants, such as pesticides and herbicides. Additional risks of 
powdered gloves include severe airway inflammation, conjunctivitis, 
dyspnea, as well as granuloma and adhesion formation when exposed to 
internal tissue. FDA's assessment of the available literature and 
information indicates that these risks are attributable to the powder 
itself, as opposed to any potential presence of manufacturing 
contaminants, such as pesticides and herbicides.
    In addition, the powder used on powdered gloves is required to 
comply with FDA's Quality System regulation, which includes 
requirements for quality and inspection for the final finished gloves 
that protect against the introduction of contaminated devices into 
commerce. Among other requirements, device manufacturers must establish 
and maintain procedures to prevent contamination of equipment or 
product by substances that could reasonably be expected to have an 
adverse effect on product quality (21 CFR 820.70(e)). FDA's Quality 
System regulation applies to gloves and glove powder sold in the United 
States, regardless of the manufacturing location.

D. Description of Comments on Scope of Ban and FDA Response

    FDA received several comments requesting revision of the scope of 
the ban. The scope of the proposed ban includes powdered surgeon's 
gloves, powdered patient examination gloves, and absorbable powder for 
lubricating a surgeon's glove. The glove types include all powdered 
patient examination and surgeon's gloves, including NRL and synthetic 
latex gloves. In the following paragraphs, we discuss and respond to 
comments requesting revision of the scope of the ban. We are finalizing 
the ban without change to the scope, but clarifying that all powdered 
patient examination gloves and powder surgical gloves are banned, 
regardless of the material from which they are made.
    (Comment 12) Several comments identify risks that result from the 
use of powdered and non-powdered NRL gloves. These comments request FDA 
to extend the ban to all NRL gloves, both powdered and non-powdered.
    (Response 12) Unlike with powdered latex gloves, which have the 
ability to aerosolize glove powder and carry allergenic proteins, FDA 
believes the risk of allergic reaction to non-powdered NRL gloves, 
which affects the user and patients in direct contact with the glove, 
is adequately mitigated through already-required labeling that alerts 
users to this risk. NRL gloves must include a statement to alert users 
to the risk of allergic reactions caused by NRL (21 CFR 801.437). 
Further, several studies have indicated that the use of non-powdered 
NRL gloves reduces the risk of sensitization to allergenic NRL proteins 
and the number of allergic reactions experienced by those who are 
already sensitized (Refs. 18, 19, and 20). FDA believes that these 
study results, when considered alongside the risk mitigation that 
follows from FDA's required labeling for NRL products, demonstrates 
that non-powdered latex gloves can be safely used with appropriate 
caution for latex-sensitive patients and health care workers. 
Therefore, FDA has determined not to ban the use of all NRL gloves.
    (Comment 13) Several comments raise the issue of life threatening 
latex allergy events that result from various uses of NRL gloves 
including food preparation and food service. Several of these comments 
assert that the Agency should broaden the scope of the ban to cover all

[[Page 91728]]

NRL gloves for all uses including food preparation and food service.
    (Response 13) We have concluded that it is not appropriate to 
address a proposal to ban gloves used for food preparation because 
these gloves do not meet the definition of a device under section 
201(h) of the FD&C Act and are thus not subject to section 516 of the 
FD&C Act (21 U.S.C. 360f), which provides the statutory authority to 
ban devices within FDA's authority to regulate such products.
    (Comment 14) One comment asserts that the ban on powdered gloves 
should not apply to dental practice, because the risks are not 
applicable to dental practice.
    (Response 14) FDA disagrees with the assertion that the risks of 
powdered gloves are not applicable to dental practice. Dentists and 
dental patients face the same risks as other medical practices in terms 
of the potential for powder exposure to open cavities or open wounds, 
and for powder, if used with NRL gloves, to carry protein allergens. 
Several studies documenting the risks of powdered gloves in dental 
practices have been conducted, including Saary, et al., which 
identified that changing to low-protein and non-powdered NRL gloves 
reduced NRL allergy in dental students (Ref. 18). In addition, Charous 
et al., 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 (Ref. 21). These studies, among others 
(Refs. 13 and 22), indicate that the risks of powdered medical gloves 
apply to dental practice. Therefore, FDA has determined that the scope 
of the ban on powdered medical gloves should continue to include 
powdered gloves used in dental practice.

E. Description of Other Specific Comments and FDA Response

    Many comments made specific remarks requesting clarification or 
revision to the proposed rule. In the following paragraphs, we discuss 
and respond to such specific comments.
    (Comment 15) A number of comments request extension of the 
effective date of the ban. The proposed rule included a proposed 
effective date of 30 days after publication of the final rule for all 
devices, including those already in commercial distribution. The 
comments suggest a range of effective dates of 90 days to 18 months 
after publication of the final rule and assert that a longer transition 
period is necessary to allow existing inventory to flow through the 
supply chain to providers and patients.
    (Response 15) FDA is not extending the effective date of the ban 
for devices already in commercial distribution. We have concluded 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. The continued marketing of these devices beyond the 30 day 
effective date would allow for the continued sale and purchase of 
devices that FDA has determined present an unreasonable and substantial 
risk to patients and health care workers. Therefore, FDA does not 
believe that it is in the best interest of the public health to extend 
the effective date for devices already in commercial distribution. In 
order to minimize the risk of continued exposure of health care workers 
and patients to these devices, the effective date for devices remains 
30 days after the date of publication of this final rule.
    (Comment 16) One comment requests that FDA not extend the effective 
date of the ban to allow companies to deplete their inventory of the 
devices.
    (Response 16) As described in the response to comment 15, FDA 
agrees that it is in the best interest of the public health to not 
extend the effective date of the ban for devices already in commercial 
distribution. Therefore, the effective date of the ban for devices 
already in commercial distribution remains at 30 days after the date of 
publication of the final rule.
    (Comment 17) A few comments request recommendations on the means of 
disposal or recycling of powdered gloves.
    (Response 17) FDA recommends that unused inventories of powdered 
medical gloves remaining at domestic manufacturing and distribution 
locations be disposed of in accordance with standard industry 
practices. Unused supplies at hospitals, outpatient centers, clinics, 
medical and dental offices, other service delivery points (nursing 
homes, etc.), and in the possession of end users, will need to be 
disposed of according to established procedures of the local 
community's solid waste management system. Established procedures for 
these materials typically involve disposal in landfills or 
incineration. FDA has concluded that this final rule will not have a 
significant impact on the human environment. (See Section VII. Analysis 
of Environmental Impact.)
    (Comment 18) One comment requests clarification on whether after 
the effective date of the ban the Agency will permit a manufacturer to 
export powdered medical gloves that are already physically located at 
distribution centers in the United States.
    (Response 18) After the effective date of this final rule, 
manufacturers will not be allowed to import powdered medical gloves. 
However, while powdered medical gloves will be banned in the United 
States on the effective date of this final rule, manufacturers may 
export existing inventory of powdered gloves to a foreign country if 
the device complies with the laws of that country and has valid 
marketing authorization by the appropriate authority, as described in 
section 802 of the FD&C Act (21 U.S.C. 382)). If eligible for export 
under section 802 of the FD&C Act, a device intended for export will 
not be deemed adulterated or misbranded if it
    (A) accords to the specifications of the foreign purchaser,
    (B) is not in conflict with the laws of the country to which it is 
intended for export,
    (C) is labeled on the outside of the shipping package that it is 
intended for export, and
    (D) is not sold or offered for sale in domestic commerce.

V. Effective Date

    This rule is effective January 18, 2017. The effective date of this 
rule applies to devices already in commercial distribution and those 
already sold to the ultimate user, as well as to devices that would be 
sold or distributed in the future. All powdered surgeon's gloves, 
powdered patient examination gloves, and absorbable powder for 
lubricating a surgeon's gloves must be removed from the market upon the 
effective date of this final rule. Section 501(g) of the FD&C Act (21 
U.S.C. 351(g)) deems a device to be adulterated if it is a banned 
device.

VI. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final 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,

[[Page 91729]]

and other advantages; distributive impacts; and equity). We have 
developed a comprehensive Economic Analysis of Impacts that assesses 
the impacts of the final rule. We believe that this final 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 certify that the 
final rule will 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 issuing ``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 $146 
million, using the most current (2015) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.

B. Summary of Costs and Benefits

    The final rule prohibits 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.
    The final 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. 
Extensive searches of glove distributor pricing indicate that 
improvements to non-powdered gloves have made these products as 
affordable as powdered gloves. The ban is expected to reduce the 
adverse events associated with using powdered gloves. The Agency 
estimates maximum total annual net benefits to range between $26.8 
million and $31.8 million. The present discounted value of the 
estimated benefits over 10 years ranges from $228.9 million to $270.8 
million at a 3 percent discount rate and from $188.5 million to $223 
million at a 7 percent discount rate.
    FDA has examined the economic implications of the rule as required 
by the Regulatory Flexibility Act. If a rule will have a significant 
economic impact on a substantial number of small entities, the 
Regulatory Flexibility Act requires us to analyze regulatory options 
that would lessen the economic effect of the rule on small entities. 
This rule will not impose any new burdens on small entities, and thus 
will not impose a significant economic impact on a substantial number 
of small entities.
    The full discussion of the economic impacts of the rule, which 
includes a list of changes made in the final regulatory impact 
analysis, 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 
(FDA-2015-N-5017) for this rule and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm# (Ref. 23).

VII. Analysis of Environmental Impact

    FDA has carefully considered the potential environmental effects of 
this final rule and of possible alternative actions. In doing so, the 
Agency 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 at municipal solid waste (MSW) 
facilities nationwide. The selected 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 from user facilities to MSW facilities 
nationwide, followed by a rapid decrease in the rate of disposal of 
these devices, as supplies are depleted. The selected 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 selected action is 
expected to have no significant impact on MSW and landfill facilities 
and the environment in affected communities.
    The Agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The Agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an EA, may be seen in the Division of Dockets Management 
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday (Ref. 
24).

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
FDA is not required to seek clearance by Office of Management and 
Budget under the Paperwork Reduction Act of 1995.

IX. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we conclude that the rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

X. 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. ``ASTM D6124 Standard Test Method for Residual Powder on Medical 
Gloves,'' 2011, available at: https://www.astm.org/Standards/D6124.htm.
3. Cote, S.J., M.D. Fisher, J.N. Kheir, et al., ``Ease of donning 
commercially available latex examination gloves,'' Journal of 
Biomedical Matererials Research, 43(3):331-337, 1998, available at: 
https://

[[Page 91730]]

www.ncbi.nlm.nih.gov/pubmed/9730072.
4. Korniewicz, D.M., M.M. El-Masri, J.M. Broyles, et al., ``A 
laboratory-based study to assess the performance of surgical 
gloves,'' AORN Journal, 77(4):772-779, 2003, available at: https://www.ncbi.nlm.nih.gov/pubmed/12705733.
5. 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, available at: https://www.ncbi.nlm.nih.gov/pubmed/15559332.
6. 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.ncbi.nlm.nih.gov/pubmed/10595890.
7. 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.ncbi.nlm.nih.gov/pubmed/11944004.
8. Patel, H.B., G.J. Fleming, and F.J. Burke, ``Puncture resistance 
and stiffness of nitrile and latex dental examination gloves,'' 
British Dental Journal, 196(11):695-700; discussion 685; quiz 707, 
2004, available at: https://www.ncbi.nlm.nih.gov/pubmed/15192735.
9. Rego, A. and L. Roley, ``In-use barrier integrity of gloves: 
latex and nitrile superior to vinyl,'' American Journal of Infection 
Control, 27(5):405-410, 1999, available at: https://www.ncbi.nlm.nih.gov/pubmed/10511487.
10. Sawyer, J. and A. Bennett, ``Comparing the level of dexterity 
offered by latex and nitrile SafeSkin gloves,'' Annals of 
Occupational Hygiene, 50(3):289-296, 2006, available at: https://www.ncbi.nlm.nih.gov/pubmed/16357028.
11. ASTM, ``ASTM D3577-01a Standard Specification for Rubber 
Surgical Gloves,'' 2001.
12. ASTM, ``ASTM D3578-01a Standard Specification for Rubber 
Examination Gloves,'' 2001.
13. Zarra, T. and T. Lambrianidis, ``Skin reactions amongst Greek 
endodontists: a national questionnaire survey,'' International 
Endodontic Journal, 48(4):390-398, 2015, available at: https://www.ncbi.nlm.nih.gov/pubmed/24889504.
14. Aghaee, A., H. Parsa, M. Nassiri Asl, et al., ``Comparison of 
the Effects of Powdered and Powder-free Surgical Gloves on 
Postlaparotomy Peritoneal Adhesions in Rats,'' Iranian Red Crescent 
Medical Journal, 15(5):442-443, 2013, available at: https://www.ncbi.nlm.nih.gov/pubmed/24349737.
15. Bensefa-Colas, L., M. Telle-Lamberton, S. Faye, et al., 
``Occupational contact urticaria: lessons from the French National 
Network for Occupational Disease Vigilance and Prevention (RNV3P),'' 
British Journal of Dermatology, 173(6):1453-1461, 2015, available 
at: https://www.ncbi.nlm.nih.gov/pubmed/26212252.
16. Palosuo, T., I. Antoniadou, F. Gottrup, et al., ``Latex medical 
gloves: time for a reappraisal,'' International Archives of Allergy 
and Immunology, 156(3):234-246, 2011, available at: https://www.ncbi.nlm.nih.gov/pubmed/21720169.
17. GIA, Global Industry Analysts, Inc., ``Disposable Medical 
Gloves: A Global Strategic Business Report,'' 2008.
18. 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 
and Clinical Immunology, 109(1):131-135, 2002, available at: https://www.ncbi.nlm.nih.gov/pubmed/11799379.
19. Tarlo, S.M., A. Easty, K. Eubanks, et al., ``Outcomes of a 
natural rubber latex control program in an Ontario teaching 
hospital,'' Journal of Allergy and Clinical Immunology, 108(4):628-
633, 2001, available at: https://www.ncbi.nlm.nih.gov/pubmed/11590392.
20. Allmers, H., J. Schmengler, and C. Skudlik, ``Primary prevention 
of natural 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.ncbi.nlm.nih.gov/pubmed/12170275.
21. Charous, B.L., P.J. Schuenemann, and M.C. Swanson, ``Passive 
dispersion of latex aeroallergen in a healthcare facility,'' Annals 
of Allergy, Asthma and Immunology, 85(4):285-290, 2000, available 
at: https://www.ncbi.nlm.nih.gov/pubmed/11061471.
22. Dave, J., M.H. Wilcox, and M. Kellett, ``Glove powder: 
implications for infection control,'' Journal of Hospital Infection, 
42(4):283-285, 1999, available at: https://www.ncbi.nlm.nih.gov/pubmed/10467541.
23. ``Final Regulatory Impact Analysis, Final Regulatory Flexibility 
Analysis, and Final Unfunded Mandates Reform Act Analysis for Banned 
Devices; Proposal to Ban Powdered Surgeon's Gloves, Powdered Patient 
Examination Gloves, and Absorbable Powder for Lubricating a 
Surgeon's Glove,'' available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm#.
24. FDA, ``Finding of No Significant Impact (FONSI) and 
Environmental Analysis for Banned Devices; Proposal to Ban Powdered 
Surgeon's Gloves, Powdered Patient Examination Gloves, and 
Absorbable Powder for Lubricating a Surgeon's Glove.''

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, 21 CFR parts 
878, 880, and 895 are amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 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 section 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 
intended to be worn on the hands of 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 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 section 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 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.
* * * * *

[[Page 91731]]

PART 895--BANNED DEVICES

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

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

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


Sec.  895.102   Powdered surgeon's glove.

    (a) Identification. A powdered surgeon's glove is a device intended 
to be worn on the hands of operating room personnel to protect a 
surgical wound from contamination. A powdered surgeon's glove 
incorporates powder for purposes other than manufacturing.
    (b) [Reserved]

0
8. Add Sec.  895.103 to read as follows:


Sec.  895.103   Powdered patient examination glove.

    (a) Identification. A powdered patient examination glove is a 
disposable device 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.
    (b) [Reserved]

0
9. Add Sec.  895.104 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: December 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30382 Filed 12-16-16; 8:45 am]
 BILLING CODE 4164-01-P