[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Notices]
[Page 6684]
From the Federal Register Online via the Government Publishing 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for Comments; Draft Guidance for Industry and Food and Drug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publishing a notice of availability for a draft guidance document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 The draft guidance document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: [email protected].
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