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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 K904526
Device Name HYPOALLERGENIC CRANBERRY/MALAYTEX LATEX EXAM GLOVE
Applicant
Malaytex USA, Inc.
1524 Kearney St.
El Cerrito,  CA  94530
Applicant Contact P. S HEW
Correspondent
Malaytex USA, Inc.
1524 Kearney St.
El Cerrito,  CA  94530
Correspondent Contact P. S HEW
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/01/1990
Decision Date 11/23/1990
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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