LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K092498
    Device Name
    LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)
    Manufacturer
    LAGLOVE (M) SDN. BHD.
    Date Cleared
    2009-11-20

    (98 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

    Laglove TM Brand Nitrile Examination Gloves, Powdered, Non - Sterile (Pink Color) is a patient examination glove is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.

    Device Description

    Laglove TM Brand Nitrile Examination Gloves, Powdered, Non-Sterile. (Pink Color)

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for Laglove™ Brand Nitrile Examination Gloves, Powdered, Non-Sterile (Pink). This document is a regulatory approval for a medical device and thus does not contain information about an AI/ML study, device performance, acceptance criteria, or ground truth establishment.

    Therefore, I cannot provide the requested information about acceptance criteria and a study proving device meets acceptance criteria based on this document. This document pertains to the regulatory clearance of examination gloves, which are physical medical devices, not AI/ML systems.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1