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510(k) Data Aggregation

    K Number
    K212740
    Device Name
    Puravita Medical Fold Flat Surgical Mask
    Manufacturer
    Date Cleared
    2021-12-02

    (94 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Puravita M, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Puravita Medical Fold Flat Surgical Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Puravita Medical Fold Flat Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a singleuse, disposable device that is provided non-sterile.
    Device Description
    The PuraVita Medical Fold Flat Surgical Mask is a 4-layer, two panel fold-flat surgical mask. It is comprised of polypropylene spunbond inner and outer layers and two inner polypropylene meltblown filter layers. The mask is white with an extended chamber. The dimensions of each mask are length 16.3cm ± 0.5cm and width 10.6cm ± 0.5cm. The mask has nylon/spandex earloops (length 19.5cm ± 1cm) and a malleable, metal-core nosepiece (0.4cm x 8.2cm x 0.1cm) to provide a functional fit over the nose and mouth of the user. It is a non-sterile, single use, disposable device. This device is not made with natural rubber latex.
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