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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K130301
Device Name LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE)
Applicant
Elimedical Devices (Fujian), Inc.
P.O. Box 237-023
Shanghai,  CN 200237
Applicant Contact Diana Hong
Correspondent
Elimedical Devices (Fujian), Inc.
P.O. Box 237-023
Shanghai,  CN 200237
Correspondent Contact Diana Hong
Regulation Number878.4460
Classification Product Code
KGO  
Date Received02/07/2013
Decision Date 08/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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