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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 K925030
Device Name SURGEON'S GLOVE
Applicant
Wuhrlin Soplamed (M) Sdn Bhd
Lot 1,Leboh Hishamuddinb Satu
N. Klang Straits Indu. Area
42000 Port Klang,Selangor,  MY
Applicant Contact CHIN WOO
Correspondent
Wuhrlin Soplamed (M) Sdn Bhd
Lot 1,Leboh Hishamuddinb Satu
N. Klang Straits Indu. Area
42000 Port Klang,Selangor,  MY
Correspondent Contact CHIN WOO
Regulation Number878.4460
Classification Product Code
KGO  
Date Received10/05/1992
Decision Date 07/13/1993
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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