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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 K963211
Device Name UNISEAL GLOVES (LOW PROTEIN,POWDER FREE)
Applicant
American Healthcare Products, Inc.
4923 Haskell Ave.
Encino,  CA  91436
Applicant Contact TONY DJIE
Correspondent
American Healthcare Products, Inc.
4923 Haskell Ave.
Encino,  CA  91436
Correspondent Contact TONY DJIE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/16/1996
Decision Date 11/22/1996
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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