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510(k) Data Aggregation

    K Number
    K202316
    Device Name
    Medical mask (Model: KKF-1A)
    Manufacturer
    Han Zhaoqing Sporting Goods Company Limited
    Date Cleared
    2021-03-03

    (198 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K153409
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Medical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.

    Device Description

    The Medical mask are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane), and a malleable nosepiece which is placed within the binding for comfort and individualized fit. The mask not made with latex materials, and all materials are being used in currently marketed devices. The mask will be provided in white. The masks are single-use, disposable devices, provided non-sterile.

    AI/ML Overview

    The provided document is a 510(k) Premarket Notification for a Medical Mask (Model: KKF-1A). It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than an AI-powered medical device.

    Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device (e.g., sample size for AI test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this document. The document describes a traditional medical device (a mask) and standard testing for physical properties and biological safety.

    However, I can extract the acceptance criteria and performance data for the medical mask based on the provided tables.

    Acceptance Criteria and Reported Device Performance for the Medical Mask (Model: KKF-1A)

    Item (Performance Test)Acceptance Criteria for Level 1 (ASTM F2100-19)Reported Device Performance (Test Results)
    Fluid Resistance Performance (mmHg) ASTM F186229 out of 32 pass at 80 mmHgPassed at 80 mmHg
    Particulate Filtration Efficiency Performance (%) ASTM F2299≥ 95%Passed at 99.3%
    Bacterial Filtration Efficiency Performance (%) ASTM F2101≥ 95%Passed at 98.1%
    Differential Pressure (Delta-P) (mm H2O/cm²) MIL-M-36954C
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