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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K962837
Device Name NULIFE
Applicant
Med-Tech Rubber & Engineering Industries
B-4/5 Byculla Service
Industries Premises
Sussex Rad, Yculla,,  IN 400027
Applicant Contact YOGESH R SHAH
Correspondent
Med-Tech Rubber & Engineering Industries
B-4/5 Byculla Service
Industries Premises
Sussex Rad, Yculla,,  IN 400027
Correspondent Contact YOGESH R SHAH
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/09/1996
Decision Date 10/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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