FDA 510(k) Application Details - K090513

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K090513
Device Name	Vinyl Patient Examination Glove
Applicant	SHANDONG HUAYUE GLOVE CO., LTD. EAST OF YIFAN/NORTH OF NAQI RD ZHANGDIAN, SHANDONG CN Other 510(k) Applications for this Company
Contact	JINYOU LIN 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	02/26/2009
Decision Date	05/08/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review