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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 K122266
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Applicant
SHANDONG JUNFENG INDUSTRIES CO., LTD
room 1606 bldg. 1. jianxiang yuan
bo. 209 bei si huan
beijing, 
Contact chu xiaoan
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/30/2012
Decision Date 09/27/2012
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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