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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 K140610
Device Name NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)
Applicant
Hartalega NGC Sdn. Bhd.
C-G-9, Jalan Dataran Sd1
Bandar Sri Damansara,  MY 52200
Applicant Contact NURUL AISYAH KONG
Correspondent
Hartalega NGC Sdn. Bhd.
C-G-9, Jalan Dataran Sd1
Bandar Sri Damansara,  MY 52200
Correspondent Contact NURUL AISYAH KONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/10/2014
Decision Date 06/20/2014
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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