FDA 510(k) Applications for Medical Device Product Code: ONT (N95 Respirator With Antimicrobial/Antiviral Agent)

FDA 510(k) Applications for Medical Device Product Code "ONT"
(N95 Respirator With Antimicrobial/Antiviral Agent)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K122702	FILLIGENT LIMITED	BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR	03/18/2013
K093161	GLAXOSMITHKLINE CONSUMER HEALTHCARE	ACTIPROTECT UF N95 RESPIRATOR	05/10/2010
K081923	GLAXOSMITHKLINE CONSUMER HEALTHCARE	ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD	07/01/2009
K120244	NEXERA MEDICAL INC	SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR	07/05/2012
K150729	Nexera Medical Inc.	SpectraShield 9500 Surgical N95 Respirator	12/29/2015
K090414	NEXERA MEDICAL, INC	SPECTRASHIELD 9500 SURGICAL MASK	02/24/2011