FDA 510(k) Application Details - K220427

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K220427
Device Name	Polymer Patient Examination Glove
Applicant	One Glove Industrial SDN BHD 24, 1st floor, Kompleks Kota Mulia, Jalan Long Jaafar, Taiping 34000 MY Other 510(k) Applications for this Company
Contact	Marcus Low 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	02/15/2022
Decision Date	05/10/2022
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