LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K062067
    Device Name
    TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2006-09-06

    (47 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 gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)

    This device is not intended to be used as a chemical barrier.

    Device Description

    Textured Powder Free BP2000 (Butadiene Polymer) Exam Gloves, Natural color

    AI/ML Overview

    This document is a 510(k) clearance letter for "Textured Power-Free BP 2000 (Butadiene Polymer) Examination Gloves, Natural Color." It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes, expert involvement, or adjudication methods.

    The document is a regulatory approval notice, not a study report. Therefore, I cannot extract the requested information from the given input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1