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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name polymer patient examination glove
510(k) Number K121192
Device Name NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)
Applicant
TEKMEDIC (M) SDN BHD
plot 4, tanjung kling
tanjung bruas jetty, tanjung kling,  MY 76400
Applicant Contact patrick leong
Correspondent
TEKMEDIC (M) SDN BHD
plot 4, tanjung kling
tanjung bruas jetty, tanjung kling,  MY 76400
Correspondent Contact patrick leong
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/19/2012
Decision Date 08/03/2012
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
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