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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 K162923
Device Name NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE
Applicant
Hartalega NGC Sdn. Bhd.
Kawasan Perindustrian Tanjung
Sepang,  MY 43900
Applicant Contact KUAN MUN LEONG
Correspondent
Hartalega NGC Sdn. Bhd.
C-G-9, Jalan Dataran Sd1
Dataran Sd Pju 9c
Bandar Sri Damansara,  MY 52200
Correspondent Contact NURUL AISYAH KONG BT ABDULLAH
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received10/18/2016
Decision Date 02/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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