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510(k) Data Aggregation

    K Number
    K210256
    Device Name
    CiRx (R) Surgical Mask
    Manufacturer
    Ningbo Shun Ye Medical Company, Ltd.
    Date Cleared
    2021-08-19

    (199 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K122717
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended for single use by operating room personnel healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluid, and particulate materials.

    Device Description

    The device is single use multi-layer surgical mask with outer layer and inner layer (spunbond plypropylene) that sandwich a meltblown polypropylene filter material. The surgical mask is secured on user via earloops. Earloops are made of polyester and spandex. The nose piece is a plastic covered iron strip. The materials used to make the surgical mask are being used in currently marketed surgical masks.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance of the CiRx® Surgical Mask based on non-clinical testing. It does not mention any studies involving AI, human readers with or without AI assistance, or the creation of ground truth by experts in a clinical context. Therefore, many of the requested fields cannot be filled from the given document.

    Here's the information extracted from the document:

    1. A table of acceptance criteria and the reported device performance:

    Performance Test (Test Methodology)Acceptance CriteriaReported Device Performance
    Synthetic Blood Penetration Resistance (ASTM F1862)29 out of 32 pass at 160 mmHgPass at 160 mmHg. Synthetic blood penetration was not seen. Four lots were tested, with 32 out of 32 passing for each lot.
    Bacterial Filtration Efficiency (BFE) (ASTM F2101-19)≥ 98%Pass, ≥ 99.7%. Four lots were tested.
    Particle Filtration Efficiency (PFE) (ASTM F2299)≥ 98%Pass, ≥ 99.814%. Four lots were tested.
    Differential Pressure (Delta P) (ASTM F2100-19)
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