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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 K014288
Device Name DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS
Applicant
Wrp Specialty Products Sdn. Bhd.
Lot11 Jalan2 Perusahaan Bandar
Kawasan Baru Salak Tinggi
Sepang, Selangor,  MY 43900
Applicant Contact MOHD H HUSSEIN
Correspondent
Wrp Specialty Products Sdn. Bhd.
Lot11 Jalan2 Perusahaan Bandar
Kawasan Baru Salak Tinggi
Sepang, Selangor,  MY 43900
Correspondent Contact MOHD H HUSSEIN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received12/28/2001
Decision Date 02/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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