FDA 510(k) Application Details - K231439

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K231439
Device Name	Polymer Patient Examination Glove
Applicant	S&S Glove Corporation Lot 4, D6 Road, Dat Do I Industrial Park Phuoc Long Tho Commune Ba Ria-Vung Tau VN790000 VN Other 510(k) Applications for this Company
Contact	Poppy Farrah Rossa 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	05/17/2023
Decision Date	08/11/2023
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