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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 K120358
Device Name POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Original Applicant
HONGXIN PLASTIC PRODUCTS CO., LTD
rm 1606 building, 1 jian xiang
yuan no. 209 bei si huan zhong
road hai di, beijing,  CN 100083
Original Contact chu xiaoan
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/06/2012
Decision Date 03/06/2012
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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