Document ID: FDA-2011-N-0027-0001
Agency: fda
Document Type: Notice
Title: Information Related to Risks and Benefits of Powdered Gloves
Posted Date: 2011-02-07T05:00Z

[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Notices]
[Page 6684]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2542]

[[Page 6683]]

Vol. 76

Monday,

No. 25

February 7, 2011

Part III

Department of Health and Human Services

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Food and Drug Administration

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 Information Related to Risks and Benefits of Powdered Gloves; Request 
for Comments; Draft Guidance for Industry and Food and Drug 
Administration Staff; Recommended Warning for Surgeon's Gloves and 
Patient Examination Gloves That Use Powder; Notices

  Federal Register / Vol. 76 , No. 25 / Monday, February 7, 2011 / 
Notices  

[[Page 6684]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0027]

Information Related to Risks and Benefits of Powdered Gloves; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
establishment of a public docket to receive comments related to 
surgeon's gloves and patient examination gloves (medical gloves) that 
contain or use donning or dusting powder. FDA is interested in the 
potential health effects from the use of powder on medical gloves and 
is soliciting comments regarding risks and benefits of powdered gloves. 
FDA is interested in any potential benefits of powdered gloves so that 
the Agency can consider how best to address the risks in light of any 
benefits. Elsewhere in this issue of the Federal Register, FDA is 
publishing a notice of availability for a draft guidance document 
entitled ``Recommended Warning for Surgeon's Gloves and Patient 
Examination Gloves That Use Powder.'' The draft guidance document 
provides a recommended warning statement for powdered glove labeling 
that will inform health care providers and consumers of the risks 
associated with glove powder.

DATES: The Agency encourages interested parties to submit information 
and comments by April 25, 2011.

ADDRESSES: Submit electronic comments or information 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: Paul Gadiock, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 4432, Silver Spring, MD 20993, 301-796-5736, e-
mail: paul.gadiock@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA has received two citizen petitions (FDA-2008-P-0531-001 and 
FDA-2009-P-0117-001) requesting that FDA ban powder on surgeon's gloves 
and patient examination gloves under the authority granted to FDA by 
section 516 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360f). In their submissions to FDA, the petitioners highlight the 
adverse health effects that can result from powdered glove use, 
including allergic reactions, irritation, and foreign body reactions 
resulting in inflammation, granulomas, and adhesions of peritoneal 
tissue after surgery, as well as glove powder's ability to serve as a 
carrier of endotoxin.
    FDA has considered this information and believes the petitions have 
raised legitimate concerns about the use of powdered gloves. However, 
FDA's regulatory approach to powdered gloves must consider the risks of 
these gloves in light of any benefits. For example, if powdered gloves 
offer unique benefits in performing certain procedures, FDA should 
consider such benefits in determining how the risks of powdered gloves 
should be addressed. To assist the FDA in developing its regulatory 
approach, the Agency is seeking public input regarding the risks and 
benefits of powdered gloves to determine whether such gloves present an 
unreasonable and substantial risk of illness or injury. FDA is 
interested in comments on both the risks and the benefits of powdered 
gloves; however, because the risks associated with powdered glove use 
have been extensively discussed in the citizen petitions, FDA is 
particularly interested in whether there are any potential benefits 
that powdered gloves may offer. Comments related to the benefits of 
powdered glove use should also discuss whether those benefits are 
available when using nonpowdered gloves. FDA plans to use this 
information when considering how to address the risks in light of any 
known benefits.
    Although FDA is still examining the potential risks and benefits of 
powdered medical gloves, in the interim the Agency believes the risks 
that have been identified support a recommended labeling statement 
advising health care providers and consumers of the risks presented by 
glove powder.
    Therefore, elsewhere in this issue of the Federal Register, FDA is 
publishing a notice of availability for a draft guidance document 
entitled ``Recommended Warning for Surgeon's Gloves and Patient 
Examination Gloves That Use Powder.'' The draft guidance document 
provides a recommended warning statement for powdered glove labeling 
that will inform health care providers and consumers of the risks 
associated with glove powder.
    The guidance document, when finalized, will help to address the 
risks associated with powdered medical gloves while FDA determines if 
additional measures, such as a ban, are necessary.

II. Submission of 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.

III. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES), and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but we are not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

    1. Barbara, J., M. C. Santais, D. A. Levy, et al., 
``Immunoadjuvant Properties of Glove Cornstarch Powder in Latex-
Induced Hypersensitivity,'' Clinical & Experimental Allergy, vol. 
33, pp. 106-112, 2003.
    2. Malinger, G., S. Ginath, L. Zeidel, et al., ``Starch 
Peritonitis Outbreak After Introduction of a New Brand of Starch 
Powdered Latex Gloves,'' Acta Obstetricia et Gynecologica 
Scandinavica, vol. 79, pp. 610-611, 2000.
    3. Odum, B. C., J. S. O'Keefe, W. Lara, et al., ``Influence of 
Absorbable Dusting Powders on Wound Infection,'' Journal of 
Emergency Medicine, vol. 16(6), pp. 875-879, 1998.
    4. Stratmeyer, M., ``Medical Glove Powder Report,'' (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm113316.htm), September 1997.

    Dated: February 1, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-2542 Filed 2-4-11; 8:45 am]
BILLING CODE 4160-01-P