FDA 510(k) Application Details - K190403

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K190403
Device Name	Polymer Patient Examination Glove
Applicant	Ever Global (Vietnam) Enterprise Corporation No.1 Road, Long Thanh Industrial Zone, Taman Village, Long Thanh District Long Tanh District 810000 VN Other 510(k) Applications for this Company
Contact	Jerry Lin Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2019
Decision Date	09/06/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review