FDA 510(k) Application Details - K221667

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K221667
Device Name	Latex 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	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2022
Decision Date	10/28/2022
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