LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K014284
    Device Name
    NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE
    Manufacturer
    FORMOSA GLOVE INDUSTRIAL CO., LTD.
    Date Cleared
    2002-02-15

    (50 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

    A 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

    Nitrile Patient Examination Glove, Powder-free and yellowish white

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Nitrile Patient Examination Gloves. It does not contain information about an AI/ML powered device or a study involving such a device.

    Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details, as these elements are not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1