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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 K122100
Device Name POWDERED VINYL EXAMINATION GLOVES
Original Applicant
WANG TONG XINGHUA CO., LTD
west of guo jing road
economic development district
xinghua,  CH 225700
Original Contact guo yang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/10/2012
Decision Date 08/22/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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