LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980941
    Device Name
    SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED)
    Manufacturer
    BESGLOVE MEDICARE SDN. BHD.
    Date Cleared
    1998-04-03

    (22 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 purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Safety Powderfree Blue Latex Examination Gloves (Polymer Coated)

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for "Safety Powderfree Blue Latex Examination Gloves (Polymer Coated)". This document is a regulatory approval for a medical device and does not contain any information regarding acceptance criteria, study details, or performance metrics that would be typically found in a study report.

    Therefore, I cannot extract the requested information. The document focuses on confirming the substantial equivalence of the device to a predicate device and outlining the regulatory obligations of the manufacturer.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1