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510(k) Data Aggregation

    K Number
    K231005
    Device Name
    Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2
    Date Cleared
    2023-12-05

    (242 days)

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

    Supermax Healthcare Canada-Supermax Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aurelia Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Aurelia Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, provided nonsterile.
    Device Description
    The proposed device, Aurelia Surgical Masks are three-layer masks constructed of nonwoven polypropylene. The inner and outer layers are made of spun-bonded polypropylene. The middle layer consists of 25gsm melt-blown polypyrene. The mask contains an ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of polyurethane and nylon. The nose clip which is made of 3mm aluminum flat wire. The disposable surgical face mask is available in two different specifications: ASTM Level 1 and ASTM Level 2. The masks meet the following ASTM 1 and ASTM 2 Technical standards.
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