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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 K122464
Device Name MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE
Applicant
Industrial Clothings, Ltd.
D17, Seethawaka Export Processing Zone
Avissawella, Western,  LK 10700
Applicant Contact S.N. HARI
Correspondent
Industrial Clothings, Ltd.
D17, Seethawaka Export Processing Zone
Avissawella, Western,  LK 10700
Correspondent Contact S.N. HARI
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/13/2012
Decision Date 04/12/2013
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
Predetermined Change
Control Plan Authorized		 No
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