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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 K001613
Device Name COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE 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 YUE WHA CHOW
Correspondent
Wrp Asia Pacific Sdn. Bhd.
Lot 1, Jalan 3,
Kawasan Perusahaan Bandar Baru
Salak Tinggi, Sepang Selangor,  MY 43900
Correspondent Contact YUE WHA CHOW
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/25/2000
Decision Date 11/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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