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2011-02-05
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Information Related to Risks and Benefits of Powdered Gloves; Request for Comments
Part III
Notices
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D09002ee1bdd0f555
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
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 Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability for a draft guidance document entitled ``Recommended Warning for Surgeon's Gloves and Patient Examination Gloves That Use Powder.'' The draft guidance document provides a recommended warning statement for powdered glove labeling that will inform health care providers and consumers of the risks associated with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.
76 FR 6684
https://www.govinfo.gov/app/details/FR-2011-02-07/2011-2542
2011-2542
fr07fe11-104
4160-01-P
Docket No. FDA-2011-N-0027
https://www.govinfo.gov/app/details/FR-2011-02-07/2011-2542
https://www.govinfo.gov/content/pkg/FR-2011-02-07/html/2011-2542.htm
https://www.govinfo.gov/content/pkg/FR-2011-02-07/pdf/2011-2542.pdf
1 p.
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76 FR 6684
Information Related to Risks and Benefits of Powdered Gloves; Request for Comments; Federal Register Vol. 76, Issue
NOTICE
2011-2542
III
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2011-04-25
Docket No. FDA-2011-N-0027
4160-01-P
2011-2542
Notice; request for comments.
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.
The Agency encourages interested parties to submit information and comments by April 25, 2011.
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.
Information Related to Risks and Benefits of Powdered Gloves
,
paul.gadiock@fda.hhs.gov
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm113316.htm
http://www.regulations.gov
Federal Register
Vol. 76, no. 25
Office of the Federal Register, National Archives and Records Administration
2011-02-07
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2011-02-07
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https://www.govinfo.gov/content/pkg/FR-2011-02-07/xml/FR-2011-02-07.xml
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