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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 K913642
Device Name THE BODYGUARDS PLUS HYPO ALLERGENIC LATEX EXAM GLO
Applicant
T.K. Glove Products
P.O. Box 2726
Seal Beach,  CA  90740
Applicant Contact ROSE KISLING
Correspondent
T.K. Glove Products
P.O. Box 2726
Seal Beach,  CA  90740
Correspondent Contact ROSE KISLING
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/07/1991
Decision Date 04/07/1992
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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