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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 K891498
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Carneal Enterprises, Inc. Div. Oakfield Mens Store
Oakfield Rd.
P.O. Box 1641
Jackson,  TN  38302
Applicant Contact M CARNEAL
Correspondent
Carneal Enterprises, Inc. Div. Oakfield Mens Store
Oakfield Rd.
P.O. Box 1641
Jackson,  TN  38302
Correspondent Contact M CARNEAL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/16/1989
Decision Date 04/28/1989
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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