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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 K100699
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Original Applicant
SHIJIAZHUANG STAR PLASTIC CO., LTD
room 1606 bldg.1.jianxiang
yuan no.209 bei si huan zho
beijing,  CH 100083
Original Contact chu xiaoan
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/11/2010
Decision Date 05/20/2010
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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