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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 K000139
Device Name MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED
Applicant
INDUSTRIAL CLOTHINGS, LTD.
481 A, PRINCE OF WALES AVE.
COLUMBO 14,  LK 14
Applicant Contact SYED UMAIR AHMED
Correspondent
INDUSTRIAL CLOTHINGS, LTD.
481 A, PRINCE OF WALES AVE.
COLUMBO 14,  LK 14
Correspondent Contact SYED UMAIR AHMED
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/18/2000
Decision Date 09/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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