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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name polymer patient examination glove
510(k) Number K120184
Model PWN-XX/PBN-XX/PDN-XX
Device Name POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED
Original Applicant
ENCOMPASS MEDICAL SUPPLIES ONC LIMITED
hua shen road wai gao
qiao free zone
shanghai,  CH 200131
Original Contact cj ang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/23/2012
Decision Date 05/02/2012
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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