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510(k) Data Aggregation

    K Number
    K221682
    Device Name
    Ideal Med Pro 3-Ply Disposable Face Mask
    Manufacturer
    Date Cleared
    2023-01-13

    (217 days)

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

    JSN Holdings, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    When properly worn, the surgical face mask is intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
    Device Description
    Ideal Med Pro 3-Ply Disposable Face Mask is a 3-ply, flat-pleated style surgical mask. The device is manufactured with three layers. The inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. Each mask contains elastic ear loops to secure the mask over the user's face and mouth with nose piece to fit firmly over the nose. This device is not made from any natural rubber latex. The product is sold non-sterile and intended to be disposable for single-use.
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