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ONT — N95 Respirator With Antimicrobial/Antiviral Agent Class II

FDA Device Classification

Classification Details

Product Code
ONT
Device Class
Class II
Regulation Number
878.4040
Submission Type
Review Panel
HO
Medical Specialty
General, Plastic Surgery
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K150729nexera medicalSpectraShield 9500 Surgical N95 RespiratorDecember 29, 2015
K122702filligent limitedBIOFRIEND BIOMASK N95 SURGICAL RESPIRATORMarch 18, 2013
K120244nexera medicalSPECTRASHIELD 9500 SURGICAL N95 RESPIRATORJuly 5, 2012
K090414nexera medicalSPECTRASHIELD 9500 SURGICAL MASKFebruary 24, 2011
K093161glaxosmithkline consumer healthcareACTIPROTECT UF N95 RESPIRATORMay 10, 2010
K081923glaxosmithkline consumer healthcareACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLDJuly 1, 2009