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510(k) Data Aggregation

    K Number
    K252941

    Validate with FDA (Live)

    Device Name
    HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
    Manufacturer
    O&M Halyard, Inc.
    Date Cleared
    2025-12-11

    (87 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    18 - 100
    Reference & Predicate Devices
    K232777
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HALYARD* Adult Face Mask(s) 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 intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. These are single use, disposable device(s), provided non-sterile.

    Device Description

    The HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops, is a three-layer mask, constructed of well-known non-woven materials. The mask is provided with earloops and a malleable nosepiece, placed within the bindings for comfort, to conform to the curvature of the wearer's nose.

    AI/ML Overview

    N/A

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