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510(k) Data Aggregation

    K Number
    K202594
    Device Name
    Medical Surgical Masks-Non Sterile
    Manufacturer
    Shandong T&F Nonwoven Co., LTD
    Date Cleared
    2021-01-06

    (120 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K153496
    Why did this record match?
    Device Name :

    Medical Surgical Masks-Non Sterile

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

    The Medical Surgical Masks-Non Sterile is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile.

    Device Description

    The Medical Surgical Masks-Non Sterile is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Medical Surgical Masks-Non Sterile is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided non-sterile.

    The proposed device(s) are White color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.

    The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown fabric.

    The Medical Surgical Masks-Non Sterile is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with 30% polyamide and 70% polyurethane.

    The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and iron wire.

    The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance of a Medical Surgical Mask-Non Sterile. It is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets criteria in an AI/algorithm context. Therefore, many of the requested points, such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, or specific AI-related ground truths, are not applicable to this document.

    However, I can extract the relevant information regarding the acceptance criteria and the device's performance based on the non-clinical tests conducted for this medical device.

    Acceptance Criteria and Reported Device Performance

    Title of the TestAcceptance criteria and source of referencesReported Device Performance (Results)
    In Vitro CytotoxicityNo cytotoxicity effect as the test method of ISO 10993-10Under the conditions of the study, not cytotoxicity effect
    Skin IrritationNo irritation effect as the test method of ISO 10993-5Under the conditions of the study, not an irritant
    Skin SensitizationNo sensitization effect as the test method of ISO 10993-5Under conditions of the study, not a sensitizer.
    Fluid Resistance120 mmHg as the test method of ASTM F1862120 mmHg
    Particulate Filtration Efficiency (PFE)≥98% as the test method of ASTM F2299≥99%
    Bacterial Filtration Efficiency (BFE)≥98% as the test method of ASTM F2101≥99%
    Differential Pressure (Delta P)
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