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510(k) Data Aggregation

    K Number
    K100326
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    TANGSHAN HONGDA PLASTCI PRODUCTS CO LTD
    Date Cleared
    2010-03-24

    (48 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K032908
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

    AI/ML Overview

    The following information is extracted from the provided text:

    Acceptance Criteria and Device Performance

    CharacteristicsAcceptance Criteria (Standard)Reported Device Performance
    DimensionASTM standard D 5250-06Meets
    Physical PropertiesASTM standard D 5250-06Meets
    Freedom from pinholes21 CFR 800.20Meets
    Powder ResidualASTM standard D 5250-06 & D6124-06<2mg/glove
    Biocompatability (Primary Skin Irritation)Primary Skin Irritation in rabbitsPasses (Not a Primary Skin Irritation)
    Biocompatability (Dermal Sensitization)Dermal sensitization in the guinea pigPasses (Not a Dermal sensitization)

    Study Details

    • Sample size used for the test set and data provenance: Not specified. The document states "Powder free vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10." This suggests testing was conducted according to these standards, which would define appropriate sample sizes for performance evaluation. However, the exact sample sizes and the country of origin or whether the data was retrospective or prospective are not explicitly stated.

    • Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. This device (patient examination gloves) does not typically involve expert review for ground truth establishment. The testing relies on standardized physical and chemical property assessments.

    • Adjudication method for the test set: Not applicable, as there is no mention of expert review or consensus for the ground truth.

    • If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical product (gloves), not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

    • If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical product, not an algorithm.

    • The type of ground truth used: The ground truth is based on established industry standards and regulations for medical gloves, including ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, and ISO10993-10, which define the acceptable physical and chemical properties.

    • The sample size for the training set: Not applicable. This device is a manufactured product, not a machine learning model, so there is no training set in the typical sense.

    • How the ground truth for the training set was established: Not applicable, as there is no training set. The "ground truth" for the device's performance is established by its adherence to the specified industry and regulatory standards.

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