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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 K960178
Device Name COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC)
Applicant
WEMBLEY RUBBER PRODUCTS (M) SDN BHD
LOT 1, JALAN 3,
KAWASAN PERUSAHAAN BANDAR BARU
SALAK TINGGI, SEPANG SELANGOR,  MY 43900
Applicant Contact YUE WAH CHOW
Correspondent
WEMBLEY RUBBER PRODUCTS (M) SDN BHD
LOT 1, JALAN 3,
KAWASAN PERUSAHAAN BANDAR BARU
SALAK TINGGI, SEPANG SELANGOR,  MY 43900
Correspondent Contact YUE WAH CHOW
Regulation Number878.4460
Classification Product Code
KGO  
Date Received01/16/1996
Decision Date 05/06/1996
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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