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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 K902565
Device Name ALADAN TRI-CLEAN 110 POWDERLESS LATEX GLOVE
Applicant
Aladan Corp.
P.O. Box 921548
Norcross,  GA  30092
Applicant Contact NEIL ANDERSON
Correspondent
Aladan Corp.
P.O. Box 921548
Norcross,  GA  30092
Correspondent Contact NEIL ANDERSON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/11/1990
Decision Date 07/03/1990
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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