FDA 510(k) Application Details - K192111

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K192111
Device Name	Polymer Patient Examination Glove
Applicant	Top Glove SDN BHD Lot 4969, Jalan Teratai, Batu 6, Off Jalan Meru Klang 41050 MY Other 510(k) Applications for this Company
Contact	Noor Akilah Saidin 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	08/05/2019
Decision Date	09/03/2020
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