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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 K120693
Device Name LATEX EXAMINATION GLOVES (POWDERED)
Applicant
TOP CALIBRE SDN BHD
1-1,2 JALAN SETIA PRIMA U13/S
SETIA ALAM, SEKSYEN U13
SHAH ALAM,  MY 40170
Applicant Contact TRACY NGUI
Correspondent
TOP CALIBRE SDN BHD
1-1,2 JALAN SETIA PRIMA U13/S
SETIA ALAM, SEKSYEN U13
SHAH ALAM,  MY 40170
Correspondent Contact TRACY NGUI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/07/2012
Decision Date 05/08/2012
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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