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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 K113191
Device Name POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
Original Applicant
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD
1 jian xiang yuan no. 209
bei si huan zhong rd hai di
chu xiaoan,  CH 100083
Original Contact chu xiaoan
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/31/2011
Decision Date 11/17/2011
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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