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    K Number
    K221038
    Device Name
    Disposable Medical Masks
    Manufacturer
    Hantech Medical Device Co., Ltd.
    Date Cleared
    2022-09-01

    (147 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K211899
    Why did this record match?
    Device Name :

    Disposable Medical Masks

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids.

    Device Description

    The Disposable Medical Masks are single use, three-layer, flat-folded masks with ear loops and nose clamp. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric, and the middle layer is made of melt blown Fabric. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made of Polyamide & Spandex. The nose clamp in the layers of face mask is to allow the user to fit the face mask around their nose, which is made of galvanized iron wire wrapped with PE material. The Disposable Medical Masks will be provided in white, blue, and purple which are sold non- sterile and are intended to be single use, disposable devices.

    AI/ML Overview

    This document describes the acceptance criteria and the results of a study demonstrating that the "Disposable Medical Masks" device, manufactured by Hantech Medical Device Co., Ltd., meets these criteria.

    1. Table of Acceptance Criteria and Reported Device Performance

    Test MethodologyPurposeAcceptance Criteria: ASTM F2100 Level 3Result
    Fluid Resistance, Synthetic Blood Penetration ASTM F1862Evaluate Resistance to penetration by synthetic blood (Minimum pressure in mmHg)≥ 29 samples out of 32 pass (AQL 4%) at 160 mmHg for level 3PASS (32 out of 32 passes at 160 mmHg for level 3)
    Particulate Filtration Efficiency ASTM F2299Evaluate Sub-micron particulate filtration efficiency at 0.1 micron (%) (PFE)≥ 98% (29 out of 32 pass)PASS
    Bacterial Filtration Efficiency ASTM F2101Evaluate Bacterial filtration efficiency (BFE) (%)≥ 98% (29 out of 32 pass)PASS
    Differential Pressure (Delta P) EN 14683 Annex CEvaluate Differential pressure (Delta-P)
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