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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 K001165
Device Name POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Original Applicant
MEDIPURE CORPORATION (M) SDN. BHD.
no: 14, jalan taiping
kuala kangsar, perak,  MY 33000
Original Contact lee son hong
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/10/2000
Decision Date 07/05/2000
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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