FDA 510(k) Application Details - K221424

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K221424
Device Name	Surgeon'S Gloves
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	878.4460   More FDA Info for this Regulation Number
Classification Product Code	KGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2022
Decision Date	01/26/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review