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510(k) Data Aggregation

    K Number
    K051426
    Device Name
    CARLO SURGICAL GOWN
    Manufacturer
    SOFILM TECHNOLOGY CO., LTD.
    Date Cleared
    2005-08-02

    (62 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sofilm Technology Co., Ltd. Carlo Surgical Gown is a sterile, single-use surgical gown that is 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 microorganisms, body fluids, and particulate material.

    Device Description

    Carlo Surgical Gown. Disposable, Sterile

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a surgical gown. It does not contain information about acceptance criteria, device performance, or a study to prove the device meets acceptance criteria as typically found in a clinical or performance study report.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.

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