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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 K020019
Device Name POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
Applicant
WRP ASIA PACIFIC SDN. BHD.
LOT 1, JALAN 3,
KAWASAN PERUSAHAAN BANDAR BARU
SALAK TINGGI, SEPANG SELANGOR,  MY 43900
Applicant Contact YUE W CHOW
Correspondent
WRP ASIA PACIFIC SDN. BHD.
LOT 1, JALAN 3,
KAWASAN PERUSAHAAN BANDAR BARU
SALAK TINGGI, SEPANG SELANGOR,  MY 43900
Correspondent Contact YUE W CHOW
Regulation Number878.4460
Classification Product Code
KGO  
Date Received01/03/2002
Decision Date 01/23/2002
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
Recalls CDRH Recalls
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