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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 K133949
Device Name POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Applicant
TOP CALIBRE SDN BHD
Lot 13726, Jalan Haji Salleh, Batu 5 1/4
Off Jalan Meru
KLANG, SELANGOR,  MY 41050
Applicant Contact ROSNITA MAODIN
Correspondent
TOP CALIBRE SDN BHD
Lot 13726, Jalan Haji Salleh, Batu 5 1/4
Off Jalan Meru
KLANG, SELANGOR,  MY 41050
Correspondent Contact ROSNITA MAODIN
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received12/23/2013
Decision Date 04/08/2014
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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