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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 K902181
Device Name MODIFIED NON-STERILE LATEX EXAMINATION GLOVES
Applicant
Aladan Corp.
P.O. Box 921548
Norcross,  GA  30092
Applicant Contact BRADLEY L PUGH
Correspondent
Aladan Corp.
P.O. Box 921548
Norcross,  GA  30092
Correspondent Contact BRADLEY L PUGH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/02/1990
Decision Date 06/01/1990
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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