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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 K926049
Device Name DIGITEX, DIGITEX HYPOALLERGENIC
Applicant
Mayer Laboratories
231 Fallon St.
Oakland,  CA  94607
Applicant Contact DAVID P MAYER
Correspondent
Mayer Laboratories
231 Fallon St.
Oakland,  CA  94607
Correspondent Contact DAVID P MAYER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/01/1992
Decision Date 07/22/1993
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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