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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 K892414
Device Name QUALITEX LATEX EXAMINATION GLOVES
Applicant
Agri-Bag Corp.
103 Orchard Ave.
Hayward,  CA  94544
Applicant Contact JAMES A STAUB
Correspondent
Agri-Bag Corp.
103 Orchard Ave.
Hayward,  CA  94544
Correspondent Contact JAMES A STAUB
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/13/1989
Decision Date 06/19/1989
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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