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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 K893277
Device Name LATEX EXAM GLOVES (MFG. GLOVELINE INDUSTRIES)
Applicant
China Representatives , Ltd.
61 W. 62nd St., Suite 4e
New York,  NY  10023
Applicant Contact LOUIS F SHARPE
Correspondent
China Representatives , Ltd.
61 W. 62nd St., Suite 4e
New York,  NY  10023
Correspondent Contact LOUIS F SHARPE
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/17/1989
Decision Date 08/09/1989
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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