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510(k) Data Aggregation

    K Number
    K992604
    Device Name
    HENRY SCHEIN SURGICAL MASK
    Manufacturer
    MITSUI TEXTILE CORP.
    Date Cleared
    2000-01-28

    (178 days)

    Product Code
    FXX
    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 indication for use of the Henry Schein surgical mask is as follows. These surgical masks are surgical apparel, intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the U.S. FDA 510(k) summary for the Henry Schein Surgical Mask (K992604) does not contain information about acceptance criteria, device performance studies, or details about ground truth establishment, sample sizes, or expert qualifications.

    This document is a marketing clearance letter, which states that the device is substantially equivalent to a legally marketed predicate device. It does not include the technical details of performance testing that would be found in a study report.

    Therefore, I cannot extract the requested information to fill your table and answer the questions about the study.

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