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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
Predetermined Change
Control Plan Authorized		 No
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