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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 K122453
Model SNAE-GY (SAP CODE-NME-GY)
Device Name MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY
Applicant
INDUSTRIAL CLOTHINGS, LTD.
d 17, seethawaka export
processing zone
auissawella, 
Contact s.n. hari
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/14/2012
Decision Date 04/05/2013
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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