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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 K890356
Device Name LATEX EXAMINATION GLOVES NON-STERILE
Applicant
Quest Intl., Inc.
Suite G, Executive Park Centre
6901 S. Dallas
Fort Smith,  AR  72903
Applicant Contact JOSEPH F KEARNEY
Correspondent
Quest Intl., Inc.
Suite G, Executive Park Centre
6901 S. Dallas
Fort Smith,  AR  72903
Correspondent Contact JOSEPH F KEARNEY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/24/1989
Decision Date 04/06/1989
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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