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510(k) Data Aggregation

    K Number
    K030997
    Device Name
    POWDERED VINYL EXAM GLOVES, WHITE
    Manufacturer
    HEYUAN HONGLI INDUSTRIES, INC.
    Date Cleared
    2003-05-02

    (35 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K022305
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A 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

    POWDERED VINYL EXAM GLOVES, WHITE, Class I Device, 80LYZ

    AI/ML Overview

    This is a 510(k) Summary for Powdered Vinyl Exam Gloves.
    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Standard/Test)Reported Device Performance
    ASTM D 5250-00E4Met or exceeded standard
    ASTM D 5151-99Met or exceeded standard
    ASTM D 6124-01Met or exceeded standard
    ISO 2859Met or exceeded standard
    MIL Std 105EMet or exceeded standard
    Bio-Compatibility: Dermal SensitizationMet or exceeded standard
    Bio-Compatibility: Primary Skin IrritationMet or exceeded standard
    Bio-Burden (Procedure Method 8315)Met or exceeded standard

    2. Sample Size for the Test Set and Data Provenance

    The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    This information is not applicable as the evaluations were based on standardized performance tests rather than expert interpretation of medical data or images.

    4. Adjudication Method for the Test Set

    This information is not applicable as the evaluations were based on standardized performance tests rather than human interpretation requiring adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a medical glove, not an AI-assisted diagnostic tool.

    6. Standalone (Algorithm Only) Performance Study

    A standalone performance study was not conducted as this device is a medical glove, not an algorithm.

    7. Type of Ground Truth Used

    The ground truth used was based on the objective measurements and pass/fail criteria defined by the listed industry and regulatory standards (ASTM, ISO, MIL Std, and bio-compatibility tests).

    8. Sample Size for the Training Set

    This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable as the device is not an AI/ML algorithm and therefore does not have a training set. The "ground truth" for demonstrating performance was established by the predefined specifications within the referenced ASTM, ISO, and MIL standards, and bio-compatibility testing procedures.

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