BEUDAMED
    Product Code: QOZ FDA not classified

    Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy

    Unknown

    The Barrier Face Covering is a product worn on the face covering at least the nose and mouth, with the primary purposes of source control and providing a degree of particulate filtration to reduce the amount of inhaled particulate matter. It is subject to the FDA's Enforcement Policy for Face Masks and Barrier Face Coverings during the COVID-19 public health emergency, is not formally classified by device class, and is not required to meet the performance standards for surgical masks or respirators. Product code QOZ, reviewed by the General Hospital panel. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

    Research product code QOZ 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
    QOZ
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    HO
    Submission Type
    7

    Device Characteristics

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

    Definition

    A barrier face covering is a product worn on the face, specifically covering at least the wearer’s nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate matter. The device is subject to the Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency, available https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-barrier-face-coverings-during-coronavirus-disease-covid-19-public, provided that the device does not create undue risk by following the recommendations for this device type outlined in the guidance.

    Unclassified Reason

    6

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.