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| HHS/FDA | RIN: 0910-AC32 | Publication ID: Fall 2006 |
| 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 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 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 facilitate industry compliance and enhance the safety and effectiveness of gloves. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Routine and Frequent |
| 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 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: Undetermined |
| Federalism: Undetermined | |
| Included in the Regulatory Plan: No | |
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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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