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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 K915107
Device Name KEITH A-GAURD
Applicant
Kbk Medical Products, Inc.
1685 Pattern Dr.
St. Louis,  MO  63138
Applicant Contact C.W.KEITH JR.
Correspondent
Kbk Medical Products, Inc.
1685 Pattern Dr.
St. Louis,  MO  63138
Correspondent Contact C.W.KEITH JR.
Regulation Number880.6250
Classification Product Code
LYY  
Date Received11/13/1991
Decision Date 02/11/1992
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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