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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 K982600
Device Name PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
Applicant
Wembley Rubber Products (M) Sdn Bhd
Peru Bandar Baru Salak Tinggi
43900 Sepang
Selangor, Malaysia,  MY
Applicant Contact CHOW YUE WAH
Correspondent
Wembley Rubber Products (M) Sdn Bhd
Peru Bandar Baru Salak Tinggi
43900 Sepang
Selangor, Malaysia,  MY
Correspondent Contact CHOW YUE WAH
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/27/1998
Decision Date 03/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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