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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 K143247
Device Name Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)
Applicant
Central Medicare Sdn Bhd
Pt 2609-2620, Bt 8, Jalan Changkat Jong
Teluk Intan,  MY 36000
Applicant Contact TH Chong
Correspondent
Third Party Review Group, LLC
45 Rockefeller Plaza, Suite 2000
New York,  NY  10111
Correspondent Contact DAVE YUNGVIRT
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/12/2014
Decision Date 01/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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