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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 K993215
Device Name DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE
Applicant
Wrp Specialty Products Sdn. Bhd.
Lot11, Jl.2,Kawasan Perusahaan
Bandar Baru Slak Tinggi
Selangor Daurl Ehsan, Sepang,  MY 43900
Applicant Contact OOI SOO KANG
Correspondent
Wrp Specialty Products Sdn. Bhd.
Lot11, Jl.2,Kawasan Perusahaan
Bandar Baru Slak Tinggi
Selangor Daurl Ehsan, Sepang,  MY 43900
Correspondent Contact OOI SOO KANG
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/24/1999
Decision Date 12/02/1999
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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