FDA 510(k) Application Details - K193555

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K193555
Device Name	Patient Examination Glove, Specialty
Applicant	Ever Global (Vietnam) Enterprise Corp Long Thanh Industrial Zone Taman Village Dong Nai Province 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	LZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2019
Decision Date	06/04/2020
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	N
Expedited Review