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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K161008
Device Name POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE
Applicant
HARTALEGA SDN. BHD.
DATARAN SD PJU 9
BANDAR SRI DAMANSARA,  MY 52200
Applicant Contact KUAN KAM HON
Correspondent
HARTALEGA SDN. BHD.
NO. 7 KAWASAN PERUSAHAAN SURIA
BESTARI JAYA,  MY 45600
Correspondent Contact NURUL AISYAH KONG
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/11/2016
Decision Date 07/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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