LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012499
    Device Name
    ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
    Manufacturer
    SHANGHAI ANTARES INDUSTRIES, INC.
    Date Cleared
    2001-10-16

    (74 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K012339
    Why did this record match?
    Device Name :

    ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES

    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 EXANINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

    Device Description

    Environ-NP Powder Free Synthetic Vinyl Examination Gloves

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Environ-NP Powder Free Synthetic Vinyl Examination Gloves." It discusses the regulatory approval process and includes a general "Indications for Use" statement for patient examination gloves.

    However, it does not describe any acceptance criteria, a specific study proving device performance against those criteria, or any details related to AI algorithms, ground truth, sample sizes for training/testing, expert adjudication, or MRMC studies.

    Therefore, I cannot generate the table or answer the specific questions related to acceptance criteria and study details based on this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1