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510(k) Data Aggregation

    K Number
    K212366
    Device Name
    Heartland Health Surgical Mask
    Manufacturer
    Heartland Health Products
    Date Cleared
    2022-02-19

    (204 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K131879
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The surgical mask 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 the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

    Device Description

    The surgical mask is a three-layer, flat pleated facepiece composed of a spunbond outer layer, filter layer, and spunbond (skin-contacting) inner layer. The mask is held in place with an elastic headband, and the position of the mask on the face is maintained with a nose wire and elastic beneath the chin. It is supplied non-sterile and is a single-use disposable.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided text.

    This document describes the validation of a Surgical Mask, not an AI/software device. Therefore, many of the typical acceptance criteria and study components for AI-driven medical devices (like MRMC studies, ground truth establishment by experts, training/test set provenance, etc.) are not applicable here. The study focuses on physical and biological performance characteristics of the mask according to recognized standards.

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria are primarily based on established ASTM and ISO standards for surgical masks.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance
    ASTM F1862:2017 - Fluid Resistance PerformanceEvaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream of synthetic blood.Class 3 - pass at 160mmHg
    Class 2 - pass at 120mmHg
    Class 1- pass at 80mmHgPass
    ASTM F2299:2017 - Particulate Filtration EfficiencyEvaluate filtration efficiency by comparing the particle count in the feed stream (upstream) to that in the filtrate (downstream) for the materials used in medical face masks.>98%Pass
    ASTM F2101:2019 - Bacterial Filtration EfficiencyEvaluate the effectiveness of medical face mask materials in preventing the passage of aerosolized bacteria, expressed in the percentage of a known quantity that does not pass the medical face mask material at a given aerosol flow rate.>98%Pass
    EN 14683:2019 - Differential PressureEvaluate the resistance to air flow and breathability of a medical face mask by measuring differential pressure through the materials of a mask.
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