FDA 510(k) Application Details - K172357

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K172357
Device Name	Vinyl Patient Examination Glove
Applicant	EVER GROWTH (VIETNAM) CO., LTD Long Khanh Industrial Zone, Binh Loc Ward Long Khanh Township 810000 VN Other 510(k) Applications for this Company
Contact	Che-Min Lee 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	08/03/2017
Decision Date	12/29/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review