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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 K112976
Device Name NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM
Original Applicant
HARTALEGA SND. BHD.
no. 7, kawasan perusahaan
suria
bestari jaya,  MY 45600
Original Contact nurul a kong
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/11/2011
Decision Date 02/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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