FDA 510(k) Application Details - K182308

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K182308
Device Name	Polymer Patient Examination Glove
Applicant	Sri Trang Gloves (Thailand) Co., LTD. 10 Soi 10 Phetkasem Road Hatyai 90110 TH Other 510(k) Applications for this Company
Contact	Anan Pruksanusak 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	08/24/2018
Decision Date	05/30/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review