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HHS/FDA RIN: 0910-AC32 Publication ID: Spring 2005 
Title: Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration 
Abstract: The Food and Drug Administration (FDA) is proposing to amend the sampling plans, test method, and acceptable quality levels in 21 CFR 800.20. As prescribed by this regulation, FDA samples patient examination and surgeons' gloves and examines them for visual defects and water leaks. Glove lots are considered adulterated if they do not meet specified quality levels. This proposal would clarify sampling plans and the scoring of defects, lower acceptance rates for leaking gloves, raise rejection rates for leaking gloves, and add tightened inspection schemes for reexamined glove lots. The rule is intended to facilitate industry compliance and enhance the safety and effectiveness of gloves. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 800.20 
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 371; 21 USC 374 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/31/2003  68 FR 15404 
NPRM Comment Period End  06/30/2003   
Final Action  12/00/2005   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Nancy Pirt
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6248
Fax:301 847-8145
Email: nancy.pirt@fda.hhs.gov

 
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