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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 K003019
Device Name PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE
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 Number878.4460
Classification Product Code
KGO  
Date Received09/27/2000
Decision Date 11/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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