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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 K914709
Device Name LATEX PATIENT EXAMINATION GLOVES - HYPOALLERGENIC
Applicant
Klh Medical, Inc.
5400 Mitchelldale, Suite B-5
Houston,  TX  77092
Applicant Contact LEE P TAY
Correspondent
Klh Medical, Inc.
5400 Mitchelldale, Suite B-5
Houston,  TX  77092
Correspondent Contact LEE P TAY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received10/18/1991
Decision Date 01/10/1992
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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