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510(k) Data Aggregation

    K Number
    K021546
    Device Name
    DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
    Manufacturer
    CREATIVE CONTRACT (M) SDN BHD
    Date Cleared
    2003-03-05

    (299 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

    DermAssist ™ Fluid Resistant Surgical Mask / Procedure Mask with WrapAround Visor is a high filtration 4 ply face mask is intended to be worn by an operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms body fluids and particulate materials. The WrapAround Visor is a 3M ® Anti Fogging Visor, is intended to act as a face shield or an eye shield, during instances where blood and bodily fluids may be splashed upon the surgeon or medical healthcare personnel.

    Device Description

    DermAssist ™ Fluid Resistant Surgical Mask (Tie On Style) with WrapAround Visor / Procedure Mask (Ear Loop Style) with WrapAround Visor

    AI/ML Overview

    I am sorry, but based on the provided document, the information required to answer your request is not available. The document is a 510(k) clearance letter from the FDA for a surgical mask and visor, indicating substantial equivalence to a predicate device. It does not contain details about specific acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies that would be expected for an AI/ML device.

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