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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 K983614
Device Name UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED)
Applicant
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD
SERULING 59, TAMAN KLANG JAYA
KLANG,  MY
Applicant Contact TARANI DEVI
Correspondent
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD
SERULING 59, TAMAN KLANG JAYA
KLANG,  MY
Correspondent Contact TARANI DEVI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/14/1998
Decision Date 02/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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