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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K924386
Device Name PATIENT EXAMINATION GLOVES
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 Number880.6250
Classification Product Code
LYY  
Date Received08/31/1992
Decision Date 07/13/1993
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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