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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 K120968
Device Name POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
Original Applicant
TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD
rm 1606 bldg 1
jianxiang yuan no.209 bei shi huan zho
beijing,  CN ch
Original Contact chu xiaoan
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/30/2012
Decision Date 09/19/2012
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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