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510(k) Data Aggregation

    K Number
    K964142
    Device Name
    MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    1997-02-25

    (132 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 DISPOSABLE SURGICAL DRAPES AND GOWNS

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for Medline Disposable Surgical Drapes and Gowns. This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does NOT contain information regarding:

    • Detailed acceptance criteria for specific performance metrics of the surgical drapes and gowns.
    • A study that quantitatively proves the device meets specific performance acceptance criteria.
    • Any details about sample sizes, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth types.
    • Training set information.

    The letter focuses on regulatory clearance based on substantial equivalence to existing devices, not detailed performance study results that would typically be found in a clinical study report or a more technical submission.

    Therefore, I cannot fulfill your request for the specific information points as they are not present in the provided text.

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