BEUDAMED
    Product Code: ORW FDA class 2 21 CFR 880.6260

    N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies

    General Hospital

    The N95 Respirator with Antimicrobial/Antiviral Agent for Use by the General Public in Public Health Medical Emergencies (product code ORW) is a single-use, disposable, NIOSH-approved N95 respirator intended to cover the nose and mouth of the wearer to reduce exposure to pathogenic biological particulates. In addition to standard filtration, it incorporates an antimicrobial and/or antiviral agent that kills specified pathogens under specified contact conditions. As an FDA Class 2 device under regulation 880.6260, it requires 510(k) premarket clearance and falls within the General Hospital specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    ORW
    Device Class
    FDA class 2
    Regulation Number
    880.6260
    Medical Specialty
    General Hospital
    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 N95 respirator intended for use by the general public in public health medical emergencies 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

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K093189 ACTIPROTECT UC N95 RESPIRATOR