FDA 510(k) Application Details - K092000

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K092000
Device Name	Vinyl Patient Examination Glove
Applicant	SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO. 12390 EAST END AVE. CHINO, CA 91710 US Other 510(k) Applications for this Company
Contact	JOHN ZHAO 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	07/02/2009
Decision Date	09/18/2009
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