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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 K915189
Device Name STERILETX POWDER FREE LATEX EXAMINATION GLOVES
Applicant
Transcorp
385-J Franklin Ave.
Rockaway,  NJ  07866
Applicant Contact ROBERT S KENNEDY
Correspondent
Transcorp
385-J Franklin Ave.
Rockaway,  NJ  07866
Correspondent Contact ROBERT S KENNEDY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/18/1991
Decision Date 02/27/1992
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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