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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 K111240
Device Name DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR
Applicant
Xuzhou Full Sun Medical Products , Ltd.
5748 Eaglewood Pl.
Rancho Cuamonga,  CA  91739
Applicant Contact ELIZABETH DENG
Correspondent
Xuzhou Full Sun Medical Products , Ltd.
5748 Eaglewood Pl.
Rancho Cuamonga,  CA  91739
Correspondent Contact ELIZABETH DENG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received05/03/2011
Decision Date 07/14/2011
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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