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510(k) Data Aggregation

    K Number
    K043585
    Device Name
    MEDLINE SURGICAL GOWNS
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2005-03-08

    (70 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDLINE SURGICAL GOWNS

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

    Medline Disposable Eclipse™ Surgical Gowns are surgical apparel that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of body fluids, micro-organisms, and particulate material.

    Device Description

    Medline Eclipse™ Surgical Gown

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets those criteria for the Medline Eclipse™ Surgical Gown.

    The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a legally marketed predicate device. It addresses general regulatory compliance but does not delve into the specific performance studies, acceptance criteria, or the methodology used to demonstrate those criteria.

    Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

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