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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 K122408
Device Name POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN)
Original Applicant
HONGYE PLASTIC PRODUCTS CO., LTD.
3973 schafer ave.
chino,  CA  91710
Original Contact kathy liu
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/08/2012
Decision Date 01/17/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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