FDA 510(k) Application Details - K223008

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K223008
Device Name	Vinyl Patient Examination Glove
Applicant	Jiangxi Handspro Products Solutions CO., LTD. Chuangye Avenue, Fenglin Industrial Zone of Dean County Jiujiang City 330406 CN Other 510(k) Applications for this Company
Contact	Jun Yin 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	09/29/2022
Decision Date	10/08/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review