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510(k) Data Aggregation

    K Number
    K201732
    Device Name
    Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On
    Manufacturer
    Dukal Corporation
    Date Cleared
    2021-02-16

    (236 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K192374
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dukal Corporation Level 3 Surgical Face Masks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

    Device Description

    Face Masks intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material.

    AI/ML Overview

    The provided document is a 510(k) summary for the Dukal Corporation Level 3 Surgical Face Masks. This type of document is for regulatory clearance of medical devices, demonstrating substantial equivalence to a predicate device, rather than proving that a device meets particular acceptance criteria through a clinical study. Therefore, much of the requested information about a study is not available in this text, as it describes performance testing results for a medical device (surgical face masks).

    However, I can extract the acceptance criteria (defined by ASTM F2100-19 Level 3 requirements for the subject device and ASTM F2100-11 Level 3 requirements for the predicate) and the reported device performance.

    Acceptance Criteria and Reported Device Performance

    Device: Dukal Corporation Level 3 Surgical Face Masks with Ear Loop and Level 3 Surgical Face Masks with Tie On

    TestAcceptance Criteria (ASTM F2100 Level 3 Requirements)Reported Device Performance (Dukal Corporation Level 3 Surgical Face Masks)
    ASTM F2101-Bacterial Filtration Efficiency (BFE)≥98%>99.9%
    ASTM F2299-Particulate Filtration Efficiency≥98%>99%
    EN 14683-Differential Pressure<5.0 mmH2O/cm2≤4.6 mmH2O/cm2
    ASTM F1862-Fluid ResistancePass at 160mmHg (31 out of 32 acceptable)Pass at 160mmHg (29 out of 32 test articles passed)
    16 CFR 1610-FlammabilityClass IClass I

    As indicated in the table above, the Dukal Corporation Level 3 Surgical Face Masks meet or exceed the performance requirements for ASTM F2100-19 Level 3 surgical face masks.

    The following information is not available in the provided document, as it pertains to a clinical study design, which is not typically part of a 510(k) submission for this type of device:

    1. Sample sizes used for the test set and the data provenance: Not applicable. The tests are laboratory-based performance tests, not studies on a test set of data.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance tests is established by industry standards (ASTM, EN).
    3. Adjudication method: Not applicable.
    4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not a diagnostic imaging or AI-assisted device.
    5. Standalone (algorithm only without human-in-the-loop performance): Not applicable. This is a physical medical device (face mask), not an algorithm.
    6. Type of ground truth used: For the performance data, the ground truth is established by the specified ASTM and EN standards for each test. For biocompatibility, it's defined by ISO 10993 acceptance criteria.
    7. Sample size for the training set: Not applicable.
    8. How the ground truth for the training set was established: Not applicable.
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