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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 K923901
Device Name LATEX EXAMINATION GLOVES
Applicant
Medi Tex, Inc.
652 Broadway
New York,  NY  10012
Applicant Contact MARK D RUSTAD
Correspondent
Medi Tex, Inc.
652 Broadway
New York,  NY  10012
Correspondent Contact MARK D RUSTAD
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/04/1992
Decision Date 12/04/1992
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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