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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 K960590
Device Name TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE
Applicant
Aladan Corp.
2926 Columbia Hwy.
P.O. Box 8308
Dotham,  AL  36303
Applicant Contact NEIL ANDERSON
Correspondent
Aladan Corp.
2926 Columbia Hwy.
P.O. Box 8308
Dotham,  AL  36303
Correspondent Contact NEIL ANDERSON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/12/1996
Decision Date 10/31/1996
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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