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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K033496
Device Name MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE
Applicant
Industrial Clothings, Ltd.
255 Duncanmill Rd.
Suite 904
Toronto,  CA M3B 3H9
Applicant Contact ALBINA BIANCHI
Correspondent
Industrial Clothings, Ltd.
255 Duncanmill Rd.
Suite 904
Toronto,  CA M3B 3H9
Correspondent Contact ALBINA BIANCHI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/05/2003
Decision Date 03/09/2004
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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