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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 K121528
Device Name POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
Applicant
SHEN WEI (USA), INC.
33278 central ave.,
suite 102
union city,  CA  94587
Contact albert li
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/23/2012
Decision Date 09/11/2012
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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