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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 K122465
Device Name MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK
Applicant
INDUSTRIAL CLOTHINGS, LTD.
D 17, SEETHAWAKA EXPORT
PROCESSING ZONE
AUISSAWELLA,  LK 10700
Applicant Contact S.N. HARI
Correspondent
INDUSTRIAL CLOTHINGS, LTD.
D 17, SEETHAWAKA EXPORT
PROCESSING ZONE
AUISSAWELLA,  LK 10700
Correspondent Contact S.N. HARI
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/13/2012
Decision Date 10/16/2012
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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