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510(k) Data Aggregation

    K Number
    K202214
    Device Name
    IFM Surgical Mask Model SM3
    Manufacturer
    FSSC, LLC
    Date Cleared
    2021-03-02

    (208 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K191355
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IFM Surgical Mask Model SM3 is 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

    Device Description

    The IFM Surgical Mask Model SM3 is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, melt-blown, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene melt-spunbond, white). Each mask contains ear loops to secure the mask over the user's mouth and nose and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.

    This device is not made with natural rubber latex.

    AI/ML Overview

    The document is a 510(k) Premarket Notification for the IFM Surgical Mask Model SM3. It asserts the substantial equivalence of the subject device to a predicate device, the 3M™ High Fluid-Resistant Procedure Mask (K191355, Model Number 1840).

    Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

    1. A table of acceptance criteria and the reported device performance:

    The acceptance criteria are generally aligned with ASTM F2100 Level 3 performance standards, which are demonstrated through specific test methods.

    Test Parameter / Acceptance Criteria (ASTM F2100 Level 3)Reported Device Performance (IFM Surgical Mask Model SM3)Predicate Device Performance (3M™ High Fluid-Resistant Procedure Mask, Model 1840)Comparison
    Bacterial Filtration Efficiency (BFE)≥98% as per ASTM F2101≥98% as per ASTM F2101Equal to predicate (meets or exceeds)
    Particulate Filtration Efficiency (PFE)≥98% @ 0.1 micron as per ASTM F2299≥98% @ 0.1 micron as per ASTM F2299Equal to predicate (meets or exceeds)
    Fluid Resistance160 mm Hg as per ASTM F1862160 mm Hg as per ASTM F1862Equal to predicate (meets or exceeds)
    Differential Pressure (Delta-P)
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