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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name patient examination glove, specialty
510(k) Number K120336
Device Name NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U
Original Applicant
HARTALEGA SDN BHD
no. 7, kawasan perusahaan
suria
bestari jaya,  MY 45600
Original Contact nurul aisyah kong
Regulation Number880.6250
Classification Product Code
LZC  
Date Received02/03/2012
Decision Date 06/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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