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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 K122176
Device Name POWDERED VINYL EXAMINATION GLOVES
Original Applicant
SHU TONG XINGHUA CO., LTD.
west of xi huan road
economic development district
xinghua,  CN 225700
Original Contact su song shi
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/23/2012
Decision Date 04/11/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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