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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 K150414
Device Name Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL
Applicant
Industrial Clothings (Pvt), Ltd.
D17, Seethawaka Export Processing Zone
Avissawella,  LK 10700
Applicant Contact S.N. HARI
Correspondent
Industrial Clothings (Pvt), Ltd.
D17, Seethawaka Export Processing Zone
Avissawella,  LK 10700
Correspondent Contact S.N. HARI
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/18/2015
Decision Date 06/12/2015
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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