FDA 510(k) Application Details - K233182

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K233182
Device Name	Polymer Patient Examination Glove
Applicant	Zibo Kaiyue Mould Technology Co., Ltd No. 268 Taishan Road, Guoli Town, Huantai County Zibo 256400 CN Other 510(k) Applications for this Company
Contact	Cindy Lee 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	09/28/2023
Decision Date	12/15/2023
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