LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K140610
    Device Name
    NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)
    Manufacturer
    HARTALEGA NGC SDN. BHD.
    Date Cleared
    2014-06-20

    (102 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 Nitrile Powder Free Examination Gloves -Violet Blue (VBLU) is a non-sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    The Nitrile Powder Free Examination Gloves - Dak Blue (DKBU) is a non-sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    The Nittle Powder Free Examination Gloves - Aqua Blue (ABLU) is a non-sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Nitrile Powder Free Examination Gloves- Aqua Blue (ABLU) Nitrile Powder Free Examination Gloves- Violet Blue (VBLU) Nitrile Powder Free Examination Gloves- Dark Blue (DKBU)

    AI/ML Overview

    This document is a 510(k) premarket notification for Nitrile Powder Free Examination Gloves. It details the indications for use of the gloves but does not contain information regarding detailed acceptance criteria or the specific studies used to demonstrate device performance against such criteria.

    The document primarily focuses on:

    • Regulatory Clearance: Acknowledging the review of the 510(k) application and determining substantial equivalence to legally marketed predicate devices.
    • Device Identification: Trade names (Aqua Blue, Violet Blue, Dark Blue), regulation number, regulation name, regulatory class, and product code.
    • Indications for Use: Stating that the gloves are "a non-sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."
    • Regulatory Compliance: Reminders about general controls provisions, potential additional controls, and contact information for further advice.

    Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    The document is a clearance letter and "Indications for Use" statement, not a detailed technical report or study summary.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1