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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 K894774
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
American Rubber Industries
1525 Michael Faraday Dr.
Suite 1
San Diego,  CA  92073
Applicant Contact DANIEL J DAVIS
Correspondent
American Rubber Industries
1525 Michael Faraday Dr.
Suite 1
San Diego,  CA  92073
Correspondent Contact DANIEL J DAVIS
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/27/1989
Decision Date 08/24/1989
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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