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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K132484
Device Name DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
Applicant
WRP ASIA PACIFIC SDN. BHD.
LOT 1, JALAN 3,
KAWASAN PERUSAHAAN BANDAR BARU
SALAK TINGGI, SEPANG SELANGOR,  MY 43900
Applicant Contact KIRK PENNER
Correspondent
WRP ASIA PACIFIC SDN. BHD.
LOT 1, JALAN 3,
KAWASAN PERUSAHAAN BANDAR BARU
SALAK TINGGI, SEPANG SELANGOR,  MY 43900
Correspondent Contact KIRK PENNER
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/08/2013
Decision Date 12/13/2013
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
Predetermined Change
Control Plan Authorized		 No
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