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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name latex patient examination glove
510(k) Number K023490
Device Name DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL
Applicant
WRP ASIA PACIFIC SDN. BHD.
LOT 1, JALAN 3,
KAWASAN PERUSAHAAN BANDAR BARU
SALAK TINGGI, SEPANG SELANGOR,  MY 43900
Applicant Contact YUE WAH CHOW
Correspondent
WRP ASIA PACIFIC SDN. BHD.
LOT 1, JALAN 3,
KAWASAN PERUSAHAAN BANDAR BARU
SALAK TINGGI, SEPANG SELANGOR,  MY 43900
Correspondent Contact YUE WAH CHOW
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/16/2002
Decision Date 01/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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