LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K121528
    Device Name
    POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2012-09-11

    (111 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K090194
    Why did this record match?
    Device Name :

    POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR

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

    A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

    Device Description

    The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20. The device is made out of nitrile.

    AI/ML Overview

    The provided 510(k) summary (K121528) describes the acceptance criteria and performance of Powder-Free Blue Nitrile Examination Gloves, Peppermint Scented. The study is a non-clinical performance assessment comparing the new device against established standards and a predicate device (K090194).

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    CharacteristicAcceptance Criteria (Standards)Reported Device Performance
    DimensionsASTM D6319-10Meets
    Physical PropertiesASTM D6319-10Meets
    Freedom from PinholesASTM D6319-10 & FDA 21 CFR 800.20Meets, AQL 2.5
    Powder-FreeASTM D 6124-06Meets
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1