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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 K120692
Device Name LATEX EXAMINATION GLOVES (POWDER FREE)
Original Applicant
TOP CALIBRE SDN BHD
1-1,2 jalan setia prima u13/s
setia alam, seksyen u13
shah alam,  MY 40170
Original Contact tracy ngui
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/07/2012
Decision Date 05/14/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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