LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972306
    Device Name
    POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE
    Manufacturer
    PT. IRAMA DINAMIKA LATEX
    Date Cleared
    1997-09-12

    (85 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient examination glove is a disposable device intended for medical purposes that is donned by doctors and healthcare workers as protection against possible infection/contamination when examining a patient.

    Device Description

    Powderfree Colored and Flavored Nitrile Copolymer Patient Examination Gloves.

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding "Powderfree Colored and Flavored Nitrile Copolymer Patient Examination Gloves." This document is a regulatory approval letter and does not contain any information about the acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI or performance metrics typical of studies proving device effectiveness.

    The document primarily states that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. It covers administrative aspects such as classification, general controls, and compliance with regulations.

    Therefore, I cannot provide the requested information based on the content of this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1