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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 K061551
Device Name POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)
Applicant
MEDIPURE CORPORATION (M) SDN. BHD.
LOT 12 MEDAN TASEK
TASEK INDUSTRAIL ESTATE
IPOH, PERAK,  MY 31400
Applicant Contact TERENCE LIM SIN KOOI
Correspondent
MEDIPURE CORPORATION (M) SDN. BHD.
LOT 12 MEDAN TASEK
TASEK INDUSTRAIL ESTATE
IPOH, PERAK,  MY 31400
Correspondent Contact TERENCE LIM SIN KOOI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/05/2006
Decision Date 08/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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