COMPLIANCE POLICY GUIDE (CPG)
CPG Sec. 335.700 Surgeons' Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure March 2011
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological HealthOffice 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.
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:
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-2020-D-0957.