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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 K072639
Device Name YUYUAN LATEX EXAMINATION GLOVE, POWDERED
Applicant
Shandong Yuyuan Latex Gloves Company , Ltd.
1296 Industrial Park
Linqing City,  CN 252600
Applicant Contact JESSIE SUN
Correspondent
Shandong Yuyuan Latex Gloves Company , Ltd.
1296 Industrial Park
Linqing City,  CN 252600
Correspondent Contact JESSIE SUN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/18/2007
Decision Date 11/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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