FDA 510(k) Application Details - K113685

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K113685
Device Name	Latex Patient Examination Glove
Applicant	KHAI HOAN JOINT STOCK COMPANY CAU SAT HAMPLET, LAI HUNG COMMUNE, BEN CAT DISTRICT BINH DUONG PROVINCE VM VN Other 510(k) Applications for this Company
Contact	TERENCE LIM Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2011
Decision Date	08/10/2012
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