FDA 510(k) Application Details - K230314

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K230314
Device Name	Polymer Patient Examination Glove
Applicant	New Era Medicare Sdn. Bhd. Plot 2621-2624 Teluk Intan 36000 MY Other 510(k) Applications for this Company
Contact	Fatin Nor Irdina binti Ahmad Fauzi 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	02/06/2023
Decision Date	08/16/2023
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