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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 K955055
Device Name NULIFE
Applicant
Med-Tech Rubber & Engineering Industries
35, Dauji Ln., Bhuleshwar
Bombay,  IN 400002
Applicant Contact YOGESH R SHAH
Correspondent
Med-Tech Rubber & Engineering Industries
35, Dauji Ln., Bhuleshwar
Bombay,  IN 400002
Correspondent Contact YOGESH R SHAH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/03/1995
Decision Date 01/23/1996
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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