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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 K121594
Device Name COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)
Original Applicant
TEKMEDIC (M) SDN BHD
plot 4, tanjung kling
industrial area, tanjung bruas
jetty, tanjung kling, malacca,  MY 76400
Original Contact patrick leong
Regulation Number880.6250
Classification Product Code
LYY  
Subsequent Product Code
LZC  
Date Received06/01/2012
Decision Date 10/25/2012
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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