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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name vinyl patient examination glove
510(k) Number K122656
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
Original Applicant
SHANDONG YIFAN PLASTIC PRODUCTS CO., LTD
12390 east end ave.
chino,  CA  91710
Original Contact ling zhu
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/31/2012
Decision Date 05/06/2014
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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