FDA 510(k) Application Details - K120797

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K120797
Device Name	Vinyl Patient Examination Glove
Applicant	SHANDONG SHOUGUANG KINGLIYUAN MEDICAL APPARATUS & 916 WEST 21ST STREET CHICAGO, IL 60608 US Other 510(k) Applications for this Company
Contact	KEVIN XU Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2012
Decision Date	07/27/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review