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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 K120797
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Applicant
SHANDONG SHOUGUANG KINGLIYUAN MEDICAL APPARATUS &
916 WEST 21ST STREET
CHICAGO,  IL  60608
Applicant Contact KEVIN XU
Correspondent
SHANDONG SHOUGUANG KINGLIYUAN MEDICAL APPARATUS &
916 WEST 21ST STREET
CHICAGO,  IL  60608
Correspondent Contact KEVIN XU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/15/2012
Decision Date 07/27/2012
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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