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510(k) Data Aggregation

    K Number
    K220378
    Device Name
    Sparta 3-Ply Surgical Disposable Face Mask
    Manufacturer
    Sparta East, LLC
    Date Cleared
    2022-06-30

    (140 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K202463
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sparta 3-Ply Surgical Disposable Face Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Sparta 3-Ply Surgical Disposable 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, non-sterile, disposable device.

    Device Description

    The Sparta 3-Ply Surgical Disposable Face Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the user's face. The mask outward facing layer is blue in color, using color master batch. The device is manufactured with three layers: Outer Layer: Spunbond polypropylene, Middle Layer: Melt Blown polypropylene, Inner Layer: Spunbond polypropylene. The subject device is provided non-sterile and is a single use, disposable device.

    AI/ML Overview

    The Sparta 3-Ply Surgical Disposable Face Mask is intended to protect both patients and healthcare professionals from the transfer of microorganisms, body fluids, and particulate material. It's designed for single use, non-sterile, and disposable applications in infection control practices. The device was deemed substantially equivalent to the predicate device, Disposable Surgical Mask K202463.

    Here's a breakdown of the acceptance criteria and the study details:

    1. Table of Acceptance Criteria and Reported Device Performance

    Device CharacteristicAcceptance Criteria (Predicate or Standard)Reported Device Performance (Subject Device)Comparison Analysis
    Fluid Resistance Performance (ASTM F1862-13)Not publically available (implicitly met by predicate)96 Passed (3 batches of 32)Substantially Equivalent
    Particulate Filtration Efficiency (ASTM F2299)≥ 99%≥98%Substantially Equivalent
    Bacterial Filtration Efficiency (ASTM F2101)≥ 98%0.999 (implicitly 99.9%)Substantially Equivalent
    Differential Pressure (Delta P) (EN 14683)
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