0910-AC32 200704 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria 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. Routine and Frequent Previously Published in The Unified Agenda Completed Actions No No 21 CFR 800.20 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 No NPRM 03/31/2003 68 FR 15404 NPRM Comment Period End 06/30/2003 Final Action 12/19/2006 71 FR 75865 No None NA Not Collected Nancy Pirt 0910 Food and Drug Administration FDA 301 796-6248 301 847-8145 nancy.pirt@fda.hhs.gov Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring MD 20993