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510(k) Data Aggregation

    K Number
    K212302
    Device Name
    BAYLAB 3-Ply Surgical Mask (BEACON I)
    Manufacturer
    Baylab USA, LLC
    Date Cleared
    2021-12-07

    (137 days)

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

    Baylab USA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BAYLAB 3-Ply Surgical Masks (BEACON I) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided nonsterile.
    Device Description
    BAYLAB 3-Ply Surgical Masks (BEACON I) are nonwoven, pleated, 3-ply, single use, disposable flat surgical masks, manufactured in Bay Blue color. The surgical masks are to be secured on users by means of elastic ear loops.
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