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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 K936268
Device Name COMFIT BLUE POWDERED EXAMINATION GLOVES
Applicant
Wembley Rubber Products (M) Sdn Bhd
11th Floor, Menara Apera Ulg
84, Jalan Raja Chulan 50200
Kuala Lumpur, Malaysia,  MY
Applicant Contact IBG GHEE CHEE
Correspondent
Wembley Rubber Products (M) Sdn Bhd
11th Floor, Menara Apera Ulg
84, Jalan Raja Chulan 50200
Kuala Lumpur, Malaysia,  MY
Correspondent Contact IBG GHEE CHEE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/30/1993
Decision Date 12/07/1994
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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