FDA 510(k) Application Details - K161961

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K161961
Device Name	Latex Patient Examination Glove
Applicant	UG GLOBAL RESOURCES SDN BHD Lot 62 & 63, Lorong Senawang 3/2 Kawasan Perindustrian Senawang Seremban 70450 MY Other 510(k) Applications for this Company
Contact	Wong See Keong Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2016
Decision Date	05/11/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review