FDA 510(k) Application Details - K161085

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K161085
Device Name	Polymer Patient Examination Glove
Applicant	MULTISAFE SDN. BHD. LOT 764, BIDOR INDUSTRIAL ESTATE BIDOR 35500 MY Other 510(k) Applications for this Company
Contact	THUM TECK LAM 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	04/18/2016
Decision Date	07/05/2018
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