FDA 510(k) Application Details - K170094

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K170094
Device Name	Latex Patient Examination Glove
Applicant	Viet Glove Corporation Cau Sat Hamlet, Lai Hung Commune Ben Cat District Bau Bang Province VN Other 510(k) Applications for this Company
Contact	Pham Ngoc Thanh 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	01/11/2017
Decision Date	06/23/2017
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