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510(k) Data Aggregation

    K Number
    K021539
    Device Name
    DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS
    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 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.

    Device Description

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

    AI/ML Overview

    The provided text is a 510(k) clearance letter for a surgical mask. It does not contain information about acceptance criteria, device performance, study design, or ground truth for an AI/ML powered medical device. Therefore, I cannot generate the requested table and information.

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