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510(k) Data Aggregation

    K Number
    K091421
    Device Name
    NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED)
    Manufacturer
    NOVAPRO CO., LTD.
    Date Cleared
    2009-07-23

    (71 days)

    Product Code
    LYZ
    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 Vinyl examination glove, Powder Free, Clear(Non-Colored)is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Powder-Free, Vinyl Examination Gloves, Clear (Non-Colored)

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot extract specific information about acceptance criteria for a medical device's performance, the studies conducted, sample sizes, expert qualifications, or ground truth establishment.

    The document is a US FDA 510(k) clearance letter for "Powder-Free Vinyl Gloves, Clear (Non-Colored)". It primarily concerns the regulatory process of determining substantial equivalence to a predicate device, rather than detailing scientific studies on device performance.

    While it mentions "good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)", it doesn't provide specific test results or acceptance criteria for the gloves' performance as medical devices (e.g., barrier integrity, tensile strength). The listed "indications for use" simply describe the intended purpose of the gloves.

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