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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K072401
Device Name DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
Applicant
Xuzhou Full Sun Medical Products , Ltd.
Bihe Industry Area
Yitang Town, Pizhou County
Jiangsu,  CN
Applicant Contact HSUN-HUI HUANG
Correspondent
Xuzhou Full Sun Medical Products , Ltd.
Bihe Industry Area
Yitang Town, Pizhou County
Jiangsu,  CN
Correspondent Contact HSUN-HUI HUANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/27/2007
Decision Date 10/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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