FDA 510(k) Application Details - K162146

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K162146
Device Name	Polymer Patient Examination Glove
Applicant	BRIGHTWAY HOLDINGS SDN BHD. LOT 1559, JALAN ISTIMEWA, BATU BELAH KLANG 42100 MY Other 510(k) Applications for this Company
Contact	G. BASKARAN 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	08/01/2016
Decision Date	01/05/2017
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