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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 K892081
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Tacare Products , Ltd.
17952 Lyons Cir.
Huntington Beach,  CA  92647
Applicant Contact JAMES M MACSPORRAN
Correspondent
Tacare Products , Ltd.
17952 Lyons Cir.
Huntington Beach,  CA  92647
Correspondent Contact JAMES M MACSPORRAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/03/1989
Decision Date 09/05/1989
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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