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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 K021159
Device Name POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM
Applicant
WRP ASIA PACIFIC SDN. BHD.
LOT1,JALAN3,KAWASAN PERUSAHAAN
BANDAR BARU SALAK TINGGI
SEPANG,SELANGOR DARUL EHSAN,  MY 43900
Applicant Contact K. K LEONG
Correspondent
WRP ASIA PACIFIC SDN. BHD.
LOT1,JALAN3,KAWASAN PERUSAHAAN
BANDAR BARU SALAK TINGGI
SEPANG,SELANGOR DARUL EHSAN,  MY 43900
Correspondent Contact K. K LEONG
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/11/2002
Decision Date 07/03/2002
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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