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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 K900561
Device Name GLOVEX LATEX EXAMINATION GLOVES
Applicant
Medical Latex Corp.
Karung Berkunci # 786
80990 Johor Bahru
West Malaysia,  MY
Applicant Contact CHENG CHUAN
Correspondent
Medical Latex Corp.
Karung Berkunci # 786
80990 Johor Bahru
West Malaysia,  MY
Correspondent Contact CHENG CHUAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/07/1990
Decision Date 02/13/1990
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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