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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 K121157
Device Name POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Original Applicant
SHIJAZHUANG JIUYUAN PLASTIC CO., LTD
rm 1606 bldg. 1
jianxiang yuan
beijing,  CH 100083
Original Contact chu xiaoan
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/16/2012
Decision Date 08/02/2012
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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