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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)
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 05/14/2012
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
Predetermined Change
Control Plan Authorized		 No
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