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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 K892475
Device Name POSI SHIELD (PATIENT EXAMINATION GLOVES)
Applicant
Clinical Supply
7969 Cincinnati Dayton Rd.
West Chester,  OH  45069
Applicant Contact MARK CARNAHAN
Correspondent
Clinical Supply
7969 Cincinnati Dayton Rd.
West Chester,  OH  45069
Correspondent Contact MARK CARNAHAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/07/1989
Decision Date 05/08/1989
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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