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    K Number
    K050155
    Device Name
    POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
    Manufacturer
    ZIBO ZHUANGYUAN PLASTIC & RUBBER CO., LTD.
    Date Cleared
    2005-02-07

    (14 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K032907
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Powdered 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

    powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004

    AI/ML Overview

    The provided document describes the safety and effectiveness information for "Powdered Vinyl Patient Examination Gloves, White (Non-colored)" submitted by ZIBO ZHUANGYUAN PLASTIC & RUBBER CO.,LTD. The study presented is a non-clinical evaluation comparing the device's technical characteristics against established standards.

    Here's an analysis of the acceptance criteria and study details:

    1. Table of Acceptance Criteria and Reported Device Performance:

    CharacteristicsStandardAcceptance CriteriaReported Device Performance
    DimensionASTM standard D 5250-00e4Meets ASTM standard D 5250-00e4 requirementsMeets
    Physical PropertiesASTM standard D 5250-00e4Meets ASTM standard D 5250-00e4 requirementsMeets
    Freedom from pinholes21 CFR 800.20Meets 21 CFR 800.20 requirements (implying a specific AQL for waterleak test)Meets
    Powder AmountASTM standard D 5250-00e4<10mg/dm2 (as indicated by the "Device performance" column for Biocompatability/Powder Amount)Meets (<10mg/dm2 is explicitly stated in the performance section, which is then followed by "Passes" for both a skin irritation and sensitization test)
    BiocompatibilityPrimary Skin Irritation in rabbitsNot a Primary Skin Irritation (implicitly defined by passing the test)Passes
    Dermal sensitization in the guinea pigNot a Dermal sensitization (implicitly defined by passing the test)Passes

    2. Sample Size Used for the Test Set and Data Provenance:

    • Sample Size: The document does not explicitly state the specific sample size for each characteristic test (e.g., how many gloves were tested for dimensions, pinholes, etc.). It generally refers to meeting the requirements "per ASTM D5250-00", "per ASTM D6124-01", "per 21 CFR 800.20", and "ISO10993-10". These standards would define the required sample sizes for such tests.
    • Data Provenance: The data is presented as a summary of non-clinical tests performed by the manufacturer, ZIBO ZHUANGYUAN PLASTIC & RUBBER CO.,LTD, located in China. The testing appears to be retrospective in nature, as it's a submission for regulatory review based on already conducted tests. The country of origin of the data is P.R.CHINA.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

    • This device is a Class I medical device (patient examination gloves). The "ground truth" for its performance is established by adherence to recognized industry standards (ASTM, FDA regulations, ISO) rather than expert consensus on individual cases.
    • Therefore, there were no specific "experts" in the sense of medical professionals diagnosing conditions being used to establish a ground truth for individual items in the test set. The ground truth is the standard's specification itself, and the testing laboratories or personnel would be qualified to perform the tests according to those standards.

    4. Adjudication Method for the Test Set:

    • Not applicable in the context of this device and study. The evaluation focuses on meeting predefined specifications from industrial standards, not on subjective interpretations requiring adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

    • No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret images or data, and AI assistance is being evaluated. Patient examination gloves do not involve human readers interpreting data in this manner.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

    • Yes, in spirit, the study is standalone. The device itself (the glove) is evaluated against objective, measurable criteria defined by standards. There is no "algorithm" in a software sense, but the device's physical and biological properties are assessed in a standalone manner without human intervention influencing the outcome of the measurement beyond the testing procedure itself. The performance "meets" or "passes" the specified criteria.

    7. The Type of Ground Truth Used:

    • The ground truth used is primarily objective, established performance criteria and requirements defined by international and national standards (ASTM standard D 5250-00e4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10). These standards specify acceptable ranges for dimensions, physical properties, pinhole rates, powder amount, and biocompatibility outcomes.

    8. The Sample Size for the Training Set:

    • Not applicable. This is a physical device being tested against established standards, not a machine learning algorithm that requires a "training set."

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

    • Not applicable, as there is no training set for this type of device evaluation.
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