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510(k) Data Aggregation

    K Number
    K052833
    Device Name
    GORE-TEX NON-STERILE SURGICAL GOWNS
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2006-02-15

    (132 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Medline Gore Panel Coverage Surgical Gowns and Gore Critical Coverage Surgical Gowns are surgical apparel that are intended to be worn by operating room personnel during surgical procedures to protect both the patient and the operating room personnel from transfer of micro organisms, and particulate material. The surgical gowns are available in styles with non-Gore-Tex panels comprised of a 100% polyester material.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device: "Gore-Tex Non-Sterile Surgical Gowns" manufactured by Medline Industries. This type of document does not contain the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth information, MRMC studies, or standalone performance).

    The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical studies to prove effectiveness or safety by meeting specific performance criteria.

    Therefore, I cannot provide the requested information based solely on the provided text.

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