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510(k) Data Aggregation

    K Number
    K230380
    Device Name
    Surgical Face Masks, Model: EFMDS-L50Pn BLU
    Manufacturer
    Iris USA
    Date Cleared
    2023-08-03

    (171 days)

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

    Iris USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgical Face Masks, Model: EFDS-LS-Pn BLU is intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable mask provided non-sterile.
    Device Description
    Surgical Face Masks, Model: EFMDS-L50Pn BLU
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