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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 K162646
Device Name Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
Applicant
HARTALEGA NGC SDN. BHD.
KAWASAN PERINDUSTRIAN TANJUNG,
SEPANG,  MY 43900
Applicant Contact KUAN MUN LEONG
Correspondent
HARTALEGA NGC SDN. BHD.
DATARAN SD PJU 9
BANDAR SRI DAMANSARA,,  MY 52200
Correspondent Contact NURUL AISYAH KONG BT ABDULLAH
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/22/2016
Decision Date 03/03/2017
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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