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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 K121992
Device Name POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
Original Applicant
XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO., LTD
12390 east end ave.
chino,  CA  91710
Original Contact frank liu
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/06/2012
Decision Date 10/16/2012
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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