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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 K903446
Device Name COMFIT SURGEON'S GLOVES
Applicant
Wembley Rubber Products (M) Sdn Bhd
11th Floor, Menara Apera Ulg
84, Jalan Raja Chulan 50200
Kuala Lumpur, Malaysia,  MY
Applicant Contact ENG KEAT
Correspondent
Wembley Rubber Products (M) Sdn Bhd
11th Floor, Menara Apera Ulg
84, Jalan Raja Chulan 50200
Kuala Lumpur, Malaysia,  MY
Correspondent Contact ENG KEAT
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/27/1990
Decision Date 10/01/1990
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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