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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 335.700 Surgeons' Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure March 2011

Final
Docket Number:
FDA-2013-S-0610
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Office of Regulatory Affairs

This compliance policy guide provides guidance to FDA staff on the submission of seizure recommendations for medical gloves that exceed the defect levels in 21 CFR 800.20.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-S-0610.

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