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510(k) Data Aggregation

    K Number
    K032666
    Device Name
    MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2005-03-16

    (566 days)

    Product Code
    KKX,FYA
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES

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

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

    Medline Disposable Surgical Drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and study that proves a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Medline Industries regarding their surgical gowns and drapes. It discusses the substantial equivalence of these devices to legally marketed predicate devices and outlines regulatory responsibilities. It does not include details about specific performance studies, acceptance criteria, or ground truth establishment.

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