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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 K952556
Device Name SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION 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 Received06/02/1995
Decision Date 06/26/1995
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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