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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 K113193
Device Name PATIENT EXAMINATION GLOVE
Applicant
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD
1 jian xiang yuan no. 209
bei si huan zhong rd hai di
chu xiaoan, 
Contact chu xiaoan
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/31/2011
Decision Date 12/16/2011
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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