LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K993325
    Device Name
    INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE
    Manufacturer
    INNOVATIVE GLOVES CO; LTD
    Date Cleared
    1999-11-05

    (32 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K083908
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.

    Device Description

    NITRILE LATEX EXAMINATION GLOVES, POWDERFREE

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Innovative Gloves Company, Ltd. regarding their Nitrile Examination Gloves, Powderfree. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Instead, it's a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It references an "Indications for Use" enclosure (which is provided in the third image) but does not detail the technical performance or testing methodology.

    Therefore, I cannot extract the requested information from the provided text because it is not present.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1