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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 K895804
Device Name SHANNON LATEX MEDICAL GLOVES
Applicant
Cashmor Mfg. , Ltd.
Ballinalee Rd.
Longford,  IE
Applicant Contact PATRICK GEARY
Correspondent
Cashmor Mfg. , Ltd.
Ballinalee Rd.
Longford,  IE
Correspondent Contact PATRICK GEARY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/28/1989
Decision Date 11/08/1989
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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