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510(k) Data Aggregation

    K Number
    K211063
    Device Name
    HALYARD Flexaprene Green Powder-Free Exam Glove
    Manufacturer
    O & M Halyard, Inc.
    Date Cleared
    2021-11-19

    (224 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Flexaprene Green Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    Flexaprene Green Powder-Free Exam Glove

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot provide the requested information. This document is a 510(k) clearance letter from the FDA for a medical device (Flexaprene Green Powder-Free Exam Glove). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

    The document does not contain information about:

    1. Acceptance criteria and reported device performance for a study. It only states the device's indications for use.
    2. Sample sizes used for test sets.
    3. Data provenance.
    4. Number or qualifications of experts for ground truth.
    5. Adjudication method.
    6. MRMC comparative effectiveness study results or effect sizes.
    7. Standalone algorithm performance.
    8. Type of ground truth used.
    9. Training set sample size.
    10. How ground truth for the training set was established.

    This document is a regulatory approval notice, not a study report detailing performance metrics and validation processes.

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