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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 K032942
Device Name PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE
Applicant
WRP ASIA PACIFIC SDN. BHD.
LOT 1, JALAN 3,
KAWASAN PERUSAHAAN BANDAR BARU
SALAK TINGGI, SEPANG SELANGOR,  MY 43900
Applicant Contact TERENCE LIM
Correspondent
WRP ASIA PACIFIC SDN. BHD.
LOT 1, JALAN 3,
KAWASAN PERUSAHAAN BANDAR BARU
SALAK TINGGI, SEPANG SELANGOR,  MY 43900
Correspondent Contact TERENCE LIM
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/22/2003
Decision Date 12/17/2003
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
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