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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 K021465
Device Name MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
Applicant
Industrial Clothings, Ltd.
481a, Prince Of Wales Ave.
Colombo 14,  LK
Applicant Contact UMAIR AHMED
Correspondent
Industrial Clothings, Ltd.
481a, Prince Of Wales Ave.
Colombo 14,  LK
Correspondent Contact UMAIR AHMED
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/07/2002
Decision Date 05/22/2002
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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