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510(k) Data Aggregation

    K Number
    K231618
    Device Name
    3 Layer Surgical Mask (134252531)
    Manufacturer
    Original Mattress Factory Inc.
    Date Cleared
    2023-07-28

    (56 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K202595
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    When properly worn, the 3 Layer Surgical Masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.

    Device Description

    Subject Device (3 Layer Surgical Mask) is single use, 3 layers, flat-pleated style face mask with ear loops and moldable nose piece. The outer layer and inner facing layer of face mask consist of spun-bond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains polyester / spandex blend ear loops to secure the mask over the user's face and mouth with moldable nose piece to firmly fit over the nose.

    AI/ML Overview

    Acceptance Criteria and Device Performance for 3 Layer Surgical Mask

    The provided document describes the acceptance criteria and the study that proves the device, a "3 Layer Surgical Mask," meets these criteria. The study focuses on non-clinical bench testing and biocompatibility assessments to demonstrate substantial equivalence to a predicate device (Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask, K202595).

    1. Table of Acceptance Criteria and Reported Device Performance

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance (Subject Device)Result
    Fluid Resistance Performance (ASTM F 1862)Evaluate resistance to penetration by synthetic blood (2ml high velocity stream).29 out of 32 pass at 120 mmHgLot 1: 32 out of 32 pass at 160 mmHg
    Lot 2: 32 out of 32 pass at 160 mmHg
    Lot 3: 31 out of 32 pass at 160 mmHgPASS
    Particulate Filtration Efficiency (ASTM F 2299)Measure initial particle filtration efficiency using monodispersed aerosols (0.1 um latex spheres).≥ 98% PFELot 1: 99.80%
    Lot 2: 99.83%
    Lot 3: 99.87%PASS
    Bacterial Filtration Efficiency (ASTM F 2101)Measure Bacterial Filtration Efficiency using a biological aerosol of Staphylococcus Aureus.> 98% BFELot 1: 99.8%
    Lot 2: 99.8%
    Lot 3: 99.8%PASS
    Flammability (16 CFR 1610)Determine flammability characteristics.Class 1, Normal FlammabilityLot 1: DNI (Did Not Ignite)
    Lot 2: DNI
    Lot 3: DNI
    All 3 Lots met Class 1 Flammability standardsPASS
    Differential Pressure (EN 14683:2019+AC:2019)Determine overall breathability through the mask barrier.29/32 pass at 120 mmHg.
    *   **Filtration Efficiency (PFE & BFE):** ≥ 98%.
*   **Flammability:** Class 1.
*   **Differential Pressure:**
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