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510(k) Data Aggregation

    K Number
    K214035
    Device Name
    LAITEST Medical Face Mask
    Manufacturer
    R&R Medical Corporation Ltd
    Date Cleared
    2022-09-13

    (264 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K182515
    Why did this record match?
    Device Name :

    LAITEST Medical Face Mask

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

    The LAITEST MEDICAL FACE MASK are 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 intection 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

    LAITEST Surgical Face Mask are made of 3-layer non-woven material. The masks have a Bacterial Filtration Efficiency (BFE) and Particle Filtration Efficiency (PFE) Standards of 98%, and Virus Filtration Efficiency (VFE) Standards of 99%, which can effectively protect against sub-micron particles, fine dust, biological agents (bacteria, or viruses), and fluid splashes. The masks have ear loops and nose band which can provide a comfort wear for users.

    AI/ML Overview

    The provided document is a 510(k) Premarket Notification for a surgical face mask (LAITEST Surgical Face Mask, K214035). This type of document focuses on demonstrating substantial equivalence to a previously cleared device, primarily through bench testing for safety and performance, rather than a clinical study involving human patients or complex AI algorithms.

    Therefore, the requested information (sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, detailed ground truth establishment for AI, etc.) is not applicable to this submission, as it does not describe an AI medical device or a clinical study in the typical sense.

    However, I can extract the acceptance criteria and performance data for the device based on the non-clinical (bench) tests performed.

    Here's the relevant information that can be extracted:

    1. A table of acceptance criteria and the reported device performance

    ItemPurposeAcceptance CriteriaReported Device Performance (Result)
    Fluid Resistance Performance (ASTM F1862)Determine synthetic blood penetration resistance≥29 of 32 pass at 120 mmHgPass (≥29 of 32 pass at 120 mmHg)
    Particulate Filtration Efficiency (ASTM F2299)Determine the bacterial filtration efficiency> 98%Pass (≥ 98%)
    Bacterial Filtration Efficiency (ASTM F2101)Determine submicron particulate filtration efficiency> 98%Pass (≥ 98%)
    Differential Pressure (Delta P) (EN 14683)Determine breathing resistance or differential pressure
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