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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 K942510
Device Name SCIPOTEX POWDER FREE EXAM GLOVES (UNBEADED)
Applicant
Wembley Rubber Products (M) Sdn Bhd
84,Jalan Raja Chulan
50200 Kuala Lumpur
Malaysia,  MY
Applicant Contact ONG GHEE CHEE
Correspondent
Wembley Rubber Products (M) Sdn Bhd
84,Jalan Raja Chulan
50200 Kuala Lumpur
Malaysia,  MY
Correspondent Contact ONG GHEE CHEE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/26/1994
Decision Date 08/05/1994
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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