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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 K894552
Device Name 'MED-TECH' LATEX EXAMINATION GLOVE
Applicant
Med-Tech Rubber & Engineering Industries
35, Dauji Ln., Bhuleshwar
Bombay,  IN 400002
Applicant Contact RAJNIKANT R.
Correspondent
Med-Tech Rubber & Engineering Industries
35, Dauji Ln., Bhuleshwar
Bombay,  IN 400002
Correspondent Contact RAJNIKANT R.
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/20/1989
Decision Date 10/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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