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510(k) Data Aggregation

    K Number
    K070407
    Device Name
    DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE
    Manufacturer
    DUKAL CORP.
    Date Cleared
    2007-03-26

    (42 days)

    Product Code
    FXX,200
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K061864,K051291
    Why did this record match?
    Device Name :

    DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW

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

    The Dukal medical / surgical masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.

    Device Description

    Dukal Surgical Masks are pleated 3 - ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% melt blown polypropylene filter. Ear loops are made of soft latex free elastic loops. The nose piece for all Dukal Masks is a malleable aluminum wire. Masks with splash visors have an anti fog treated plastic shield attached to masks. All of the material used in the construction of the Dukal face masks are being used in currently marketed devices (see predicate information)

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a non-sterile surgical mask (Dukal Surgical Face Mask, referenced as K070407). However, the information provided focuses primarily on regulatory aspects, device description, and intended use, rather than conducting a detailed study with specific acceptance criteria and performance data in the way a diagnostic AI device would.

    Based on the provided text, here's a breakdown regarding acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    For this surgical mask, the "acceptance criteria" are defined by the adherence to a recognized performance standard, specifically ASTM 2100-04. The document states, "Recognized Performance Standard: ASTM 2100-04 Refer to submission for applicable standards."

    The document does not explicitly list the quantitative acceptance criteria defined within ASTM 2100-04 or the specific test results showing the device performing against these criteria in a table format within the provided excerpt. It simply refers to the standard as being part of the larger submission.

    However, based on general knowledge of ASTM F2100 (which is the standard for Medical Face Mask Materials, often referred to as ASTM 2100-04 in older documents), the acceptance criteria typically cover:

    Performance MetricAcceptance Criteria (from ASTM F2100 - General Expectations, not explicitly stated in the provided text for this specific device)Reported Device Performance (Not explicitly detailed in the provided text, only a general assertion of conformance to the standard)
    Bacterial Filtration Efficiency (BFE)Typically >= 95% or >= 98% (depending on level)Implied to meet relevant level of ASTM 2100-04
    Particulate Filtration Efficiency (PFE)Typically >= 95% or >= 98% (depending on level)Implied to meet relevant level of ASTM 2100-04
    Differential Pressure (Delta P)Typically
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