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510(k) Data Aggregation

    K Number
    K023428
    Device Name
    VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE
    Manufacturer
    SHANGHAI JIAWANG INDUSTRIAL CO. LTD.
    Date Cleared
    2002-10-25

    (14 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    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

    VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a Vinyl Examination Glove. It is not a study report or clinical trial. Therefore, it does not contain any information about:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size and data provenance for a test set.
    3. Number of experts and their qualifications for ground truth establishment.
    4. Adjudication method for a test set.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This letter solely communicates the FDA's determination of substantial equivalence for the Vinyl Examination Glove to legally marketed predicate devices, allowing it to proceed to market subject to general controls. It does not provide detailed performance data or study specifics.

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