Document ID: FDA-2011-D-0030-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Staff; Availability, etc.: Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder
Posted Date: 2011-02-07T05:00Z

[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Notices]
[Pages 6685-6686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2543]

[[Page 6685]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0030]

Draft Guidance for Industry and Food and Drug Administration 
Staff; Recommended Warning for Surgeon's Gloves and Patient Examination 
Gloves That Use Powder; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Recommended Warning for 
Surgeon's Gloves and Patient Examination Gloves that Use Powder.'' This 
draft guidance document provides a recommended warning statement 
related to medical gloves that contain powder or use donning or dusting 
powder, specifically surgeon's gloves and patient examination gloves 
(medical gloves that use powder). FDA is concerned about the potential 
adverse health effects from the use of powder on medical gloves and is 
recommending that the labeling for powdered medical gloves provide a 
warning related to the potential health effects. This draft guidance is 
not final nor is it in effect at this time. Elsewhere in this issue of 
the Federal Register, FDA is announcing the establishment of a public 
docket to receive comments related to surgeon's gloves and patient 
examination gloves that contain or use donning or dusting powder.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115 (g)(5)), to ensure that the Agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 9, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Recommended Warning for Surgeon's Gloves 
and Patient Examination Gloves That Use Powder'' to the Division of 
Small Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993. Send 
one self-addressed adhesive label to assist that office in processing 
your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Subhas Malghan, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 62, rm. 3204, Silver Spring, MD 20993-0002, 301-796-2548, 
Subhas.malghan@fda.hhs.gov; or Sheila Murphey, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 2510, Silver Spring, MD 20993-0002, 301-796-6302, 
Sheila.murphey@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    Medical gloves are a significant factor in the protection of both 
patients and health care personnel in the United States. Health care 
personnel rely on medical gloves as a barrier against transmission of 
infectious diseases and contaminants when conducting surgery as well as 
in more limited interactions with patients.
    Following the recognition of acquired immunodeficiency syndrome 
(AIDS) as a major public health concern and recommendations from the 
Centers for Disease Control and Prevention that health care workers use 
appropriate barrier precautions to prevent exposure to the human 
immunodeficiency virus (HIV), FDA recognized the need for greater 
assurance that cross-contamination between patients and health care 
workers be prevented. 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 
assure that manufacturers provide an acceptable manufacturing quality 
level. FDA similarly revoked the exemption from premarket notification 
requirements for patient examination gloves.
    On December 12, 1990 (55 FR 51254), FDA published regulations 
describing certain circumstances under which surgeon's and patient 
examination gloves would be considered adulterated. The regulations 
established the sampling plans and test methods for glove leakage 
defects that the Agency would use to determine whether gloves were 
adulterated. (See 21 CFR 800.20). Subsequently, FDA initiated 
inspections of glove manufacturers to assure conformance with the 
acceptable quality levels identified in the regulation.
    In 1997, FDA issued the ``Medical Glove Powder Report'' discussing 
the potential adverse health effects of medical glove powder, along 
with alternatives and current market information available at that 
time. Adverse health events reviewed by the Medical Glove Powder Report 
included: (1) Aerosolized powder on natural rubber latex (NRL) gloves 
carrying allergenic proteins as a cause of respiratory allergic 
reactions; (2) rhinitis, conjunctivitis, and dyspnea; (3) respiratory 
problems; (4) granuloma formation; and (5) peritoneal adhesions.
    FDA is issuing this draft guidance with a recommended warning 
statement for powdered medical gloves. The statement should inform 
users of the potential adverse health effects from these devices, 
including foreign body reaction, formation of granulomas, and 
peritoneal adhesion especially with multiple surgeries. The warning 
should also include information on increases in respiratory ailments, 
and development of irritant dermatitis or Type IV allergy when glove 
powder is used on NRL gloves. In addition, the warning should state 
that powder used on NRL medical gloves can serve as a carrier for 
airborne allergenic natural rubber latex proteins.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized will represent the Agency's current thinking on ``Recommended 
Warning for Surgeon's Gloves and Patient Examination Gloves that Use 
Powder.'' It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach 
may be used, but should address the identified risks inherent to 
powdered gloves.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Recommended Warning for Surgeon's Gloves and Patient Examination 
Gloves that Use Powder,'' you may either send an e-mail request to 
dsmica@fda.hhs.gov to receive an electronic copy of the document or 
send

[[Page 6686]]

a fax request to 301-847-8149 to receive a hard copy. Please use the 
document number 1704 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 801 have been 
approved under OMB control number 0910-0485. In addition, FDA concludes 
that the labeling statement in section 4 of the guidance does not 
constitute a ``collection of information'' under the PRA. Rather, this 
labeling statement is ``public disclosure of information originally 
supplied by the Federal government to the recipient for the purpose of 
disclosure to the public.'' (5 CFR 1320.3(c)(2)).

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 1, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-2543 Filed 2-4-11; 8:45 am]
BILLING CODE 4160-01-P