FDA 510(k) Application Details - K220237

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K220237
Device Name	Polymer Patient Examination Glove
Applicant	Fujian Jixiang Medical Technology Co.,Ltd 29 Tingzhou Avenue, Cewu Town, Changting County Longyan 366399 CN Other 510(k) Applications for this Company
Contact	Jiatian Yang 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	01/27/2022
Decision Date	08/01/2022
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