LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K050968
    Device Name
    POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES
    Manufacturer
    PT. MEDISAFE TECHNOLOGIES
    Date Cleared
    2005-07-12

    (85 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

    The device is a disposable synthetic rubber examination glove intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for Powder Free, Sterilized, Polychloroprene Examination Gloves. It focuses on the regulatory approval of the device and does not contain information about acceptance criteria or a study proving its performance. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, which means that its performance is presumed to be similar to existing approved devices.

    Therefore, I cannot provide the requested information based on this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1