Product code ONT

Device name: N95 Respirator With Antimicrobial/Antiviral Agent
Medical specialty: General, Plastic Surgery
Device class: 2
Regulation number: 878.4040
Review panel: HO
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Definition: A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K150729	SpectraShield 9500 Surgical N95 Respirator	Nexera Medical, Inc.	2015-12-29
K122702	BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR	Filligent Limited	2013-03-18
K120244	SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR	Nexera Medical, Inc.	2012-07-05
K090414	SPECTRASHIELD 9500 SURGICAL MASK	Nexera Medical, Inc.	2011-02-24
K093161	ACTIPROTECT UF N95 RESPIRATOR	Glaxosmithkline Consumer Healthcare	2010-05-10
K081923	ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD	Glaxosmithkline Consumer Healthcare	2009-07-01

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