FDA 510(k) Application Details - K183354

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K183354
Device Name	Polymer Patient Examination Glove
Applicant	GX Corporation SDN BHD LOT 6491, Batu 5 3/4, Sementa, Jalan Kapar Klang 42100 MY Other 510(k) Applications for this Company
Contact	Khon Pu Foo 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	12/03/2018
Decision Date	06/20/2019
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