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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K083408
Device Name POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
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
LZC  
Subsequent Product Code
LZA  
Date Received11/18/2008
Decision Date 07/31/2009
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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