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HHS/FDA RIN: 0910-AC32 Publication ID: Spring 2007 
Title: Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria 
Abstract: The final rule amends the sampling plans, test method, and acceptable quality levels in 21 CFR part 800.20 in accordance with which FDA tests patient examination and surgeons' gloves for barrier integrity. 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 rule will 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 enhance the safety and effectiveness of gloves and harmonize acceptable quality levels with international consensus standards. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 800.20 
Legal Authority: 21 USC 321; 21 USC 334; 21 USC 351; 21 USC 352; 21 USC 360e; 21 USC 360i; 21 USC 360k; 21 USC 361; 21 USC 362 
Legal Deadline:  None
Action Date FR Cite
NPRM  03/31/2003  68 FR 15404 
NPRM Comment Period End  06/30/2003   
Final Action  12/19/2006  71 FR 75865 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
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

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