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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 Pju9
Bandar Sri Damansara,  MY 52200
Applicant Contact KUAN KAM HON
Correspondent
Hartalega Sdn Bhd
# 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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