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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 K021784
Device Name PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
Applicant
WRP ASIA PACIFIC SDN. BHD.
LOT1,JALAN3,KAWASAN PERUSAHAAN
BANDAR BARU SALAK TINGGI
SEPANG,SELANGOR,  MY 43900
Applicant Contact YUE WAH CHOW
Correspondent
WRP ASIA PACIFIC SDN. BHD.
LOT1,JALAN3,KAWASAN PERUSAHAAN
BANDAR BARU SALAK TINGGI
SEPANG,SELANGOR,  MY 43900
Correspondent Contact YUE WAH CHOW
Regulation Number878.4460
Classification Product Code
KGO  
Date Received05/30/2002
Decision Date 07/24/2002
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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