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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 K120890
Model NITRILE-80LZA
Device Name POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE
Original Applicant
SHEN WEI (USA), INC.
33278 central ave.,
suite 102
union city,  CA  94587
Original Contact albert li
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/23/2012
Decision Date 08/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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