LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213981
    Device Name
    Nitrile Examination Gloves
    Manufacturer
    Emerald Glove Manufacturing Sdn Bhd
    Date Cleared
    2022-11-12

    (327 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

    Single use disposable device intended for medical purposes that is worn on the hands of examiners to prevent contamination between the examiner and the patient.

    Device Description

    Nitrile Examination Gloves

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for Nitrile Examination Gloves. It does not contain any information about acceptance criteria, device performance, or studies related to AI/algorithm performance.

    The letter focuses on regulatory approval, stating that the device is substantially equivalent to legally marketed predicate devices. It lists the regulation number, product code, and indications for use of the gloves. It also outlines the regulatory obligations of the manufacturer.

    Therefore, I cannot provide the requested information based on this document. The questions you've asked are typically relevant to the performance evaluation of a software-as-a-medical-device (SaMD) or AI-powered medical device, which is not what this document describes.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1