LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K983723
    Device Name
    CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE
    Manufacturer
    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
    Date Cleared
    1998-12-07

    (46 days)

    Product Code
    LYY
    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

    Chlorinated, Polymer-Coated, Powder-free, Latex Patient Examination Glove

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Chlorinated, Polymer-Coated, Powder-Free Latex Examination Glove. It is a regulatory approval document and does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment relevant to the prompt's request for AI/device performance studies.

    Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include performance data or study methodologies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1