FDA 510(k) Application Details - K222074

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K222074
Device Name	Polymer Patient Examination Glove
Applicant	Zibo Langu New Material Technology Co., Ltd Room 1120-2, Entreperneurship Incurbator Center, NO.7886 Linzi Avenue Zibo 255400 CN Other 510(k) Applications for this Company
Contact	Wang Qidong 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	07/14/2022
Decision Date	10/17/2022
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