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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 K911447
Device Name LATEX EXAMINATION GLOVES (HYPOALLERGENIC)
Applicant
Aladan Corp.
P.O. Box 921548
Norcross,  GA  30092
Applicant Contact CARL COOPER
Correspondent
Aladan Corp.
P.O. Box 921548
Norcross,  GA  30092
Correspondent Contact CARL COOPER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/08/1991
Decision Date 04/16/1991
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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