BEUDAMED
    Product Code: ONT FDA class 2 21 CFR 878.4040

    N95 Respirator With Antimicrobial/Antiviral Agent

    General, Plastic Surgery

    The N95 Respirator With Antimicrobial/Antiviral Agent (product code ONT) is a Class 2 device regulated under 21 CFR 878.4040 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is a single-use, disposable, NIOSH-approved respirator intended for occupational use to reduce wearer exposure to pathogenic biological particulates, with an added antimicrobial and/or antiviral agent that kills specified pathogens under defined contact conditions. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    6
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    3
    Years Active
    6

    Research product code ONT in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    ONT
    Device Class
    FDA class 2
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 6 510(k) clearances via K numbers.

    K Number Device Name
    K150729 SpectraShield 9500 Surgical N95 Respirator
    K122702 BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
    K120244 SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR
    K090414 SPECTRASHIELD 9500 SURGICAL MASK
    K093161 ACTIPROTECT UF N95 RESPIRATOR
    K081923 ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.