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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K802641
Device Name GAMMEX SURGICAL GLOVES
Applicant
Ansell, Inc.
1500 Industrial Rd.
Dothan,  AL  36303
Correspondent
Ansell, Inc.
1500 Industrial Rd.
Dothan,  AL  36303
Regulation Number878.4460
Classification Product Code
KGO  
Date Received10/24/1980
Decision Date 12/11/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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