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510(k) Data Aggregation

    K Number
    K991559
    Device Name
    MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    1999-08-23

    (111 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD

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

    A surgical mask is a device intended to be worn by operating room personnel / t surgiour rical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

    Device Description

    Medline Prohibit Series Surgical Masks with Face Shield

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a surgical mask. It does not contain information about acceptance criteria, study details, or device performance metrics like the ones you asked for (e.g., sample size, expert qualifications, ground truth, MRMC study, standalone performance).

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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