LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K142858
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)
    Manufacturer
    Careplus (M) SDN BHD
    Date Cleared
    2015-02-09

    (131 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K201857
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    POWDER FREE NITRILE EXAMINATION GLOVE, WHITE

    AI/ML Overview

    I am sorry, but the provided document is a letter from the FDA regarding the 510(k) clearance for a "Powder Free Nitrile Examination Glove, White". It details the regulatory classification and indications for use of the device.

    This document does not contain information about:

    • Acceptance criteria and reported device performance (in a table or otherwise).
    • Details of a study (sample sizes, data provenance, ground truth, expert qualifications, adjudication methods).
    • Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
    • Training set details.

    Therefore, I cannot fulfill your request for this specific document as the information you are asking for is not present within the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1