LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K033835
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR
    Manufacturer
    MDM ENTERPRISE CORP.
    Date Cleared
    2004-01-22

    (43 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MDM ENTERPRISE CORP.

    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 fingers to prevent contamination between the patient and examiner.

    Device Description

    Disposable Powder Free Vinyl Synthetic Examination Glove, White Color

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth.

    The document is a letter from the FDA regarding a 510(k) premarket notification for a "Disposable Powder Free Vinyl Synthetic Examination Glove, White Color". It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. The "Indications for Use" section simply defines the intended use of the glove as a disposable device for medical purposes to prevent contamination.

    Therefore, I cannot fulfill your request for a description of acceptance criteria and the study that proves the device meets them.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1