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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 K120584
Model XS, S, M, L, XL
Device Name POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES
Applicant
WEALTH ON (JIANGSU) CO., LTD
5 carey st
pennington,  NJ  08534
Contact charles shen
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received02/27/2012
Decision Date 07/10/2012
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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