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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 K895970
Device Name POWDER-FREE LATEX EXAMINATION GLOVES
Applicant
Usamal Latex Products Sdn Bhd
Igb Plz., Suite 15.01
15th Floor
Jalan Kampar, Kuala Lumpur,  MY 50400
Applicant Contact FRED KINDER
Correspondent
Usamal Latex Products Sdn Bhd
Igb Plz., Suite 15.01
15th Floor
Jalan Kampar, Kuala Lumpur,  MY 50400
Correspondent Contact FRED KINDER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/13/1989
Decision Date 01/26/1990
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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