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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 K963742
Device Name LATEX EXAMINATION GLOVES, POWDERED
Applicant
Arista Medi Prima
769 Morningside Dr.
Millbrae,  CA  94030
Applicant Contact CHAIRINA BREDER
Correspondent
Arista Medi Prima
769 Morningside Dr.
Millbrae,  CA  94030
Correspondent Contact CHAIRINA BREDER
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/17/1996
Decision Date 11/20/1996
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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