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    K Number
    K111459
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
    Manufacturer
    JIANGSU ALFA GLOVE CO., LTD
    Date Cleared
    2011-06-16

    (21 days)

    Product Code
    LYZ,EXA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K091663
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color is a non-sterile 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

    Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

    AI/ML Overview

    This section describes acceptance criteria and the study proving the device meets said criteria.

    The device under consideration is "Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color."

    1. Table of Acceptance Criteria and Reported Device Performance:
    CharacteristicsAcceptance Criteria (Standard)Device Performance
    DimensionASTM standard D 5250-06 e1.Meets
    Physical PropertiesASTM standard D 5250-06 e1.Meets
    Freedom from pinholes21 CFR 800.20Meets
    Powder ResidualASTM standard D 5250-06 e1 and D6124-06< 2mg/glove
    Biocompatibility:
    Primary Skin IrritationPrimary Skin Irritation in rabbits (AAMI / ANSI / ISO 10993-10)Passes (Not a Primary Skin Irritation)
    Dermal SensitizationDermal sensitization in the guinea pig (AAMI / ANSI / ISO 10993-10)Passes (Not a Dermal sensitization)

    1. Sample Size Used for the Test Set and Data Provenance:
      The document does not explicitly state the sample sizes used for each specific test (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility). The tests are based on established ASTM standards and FDA regulations, which typically specify sampling plans. The provenance of the data is not described beyond stating that the device "meets" the requirements of these standards. It is implied that these are non-clinical studies conducted by the manufacturer for regulatory submission.

    2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
      Not applicable. This device is a physical product (gloves) and not an AI or diagnostic device that requires expert adjudication of results to establish ground truth in the same way. The "ground truth" is established by adherence to physical and chemical standards and biological safety tests.

    3. Adjudication Method for the Test Set:
      Not applicable. As noted above, this product does not involve adjudication of results by multiple experts. Compliance is determined by objective measurement against specified standards and laboratory testing protocols.

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
      Not applicable. This is not a diagnostic device or an AI-assisted system that would involve human readers.

    5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
      Not applicable. This is a physical product, not an algorithm.

    6. Type of Ground Truth Used:
      The "ground truth" for this device is based on established industry standards and regulatory requirements, including:

      • ASTM standard D 5250-06 e1 (for dimensions and physical properties).
      • 21 CFR 800.20 (for freedom from pinholes, specifically waterleak test on pinhole AQL).
      • ASTM D6124-06 (for powder residual).
      • AAMI / ANSI / ISO 10993-10 (for biocompatibility, specifically primary skin irritation and dermal sensitization).
        These are objective, measurable criteria with defined pass/fail thresholds.

    7. Sample Size for the Training Set:
      Not applicable. This device is a physical product and does not involve machine learning or AI models, therefore, there is no "training set" in the context of data used for algorithm development.

    8. How the Ground Truth for the Training Set Was Established:
      Not applicable, as there is no training set for this device.

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