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510(k) Data Aggregation

    K Number
    K252830

    Validate with FDA (Live)

    Date Cleared
    2026-01-12

    (129 days)

    Product Code
    Regulation Number
    878.4040
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transferring of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

    Device Description

    The subject Disposable Surgical Face Masks has two models, that is Model: 3P00B, ASTM F2100 Level 2 and Model: C2900, ASTM F2100 Level 3.

    The Disposable Surgical Face Masks (Model: 3P00B, Level 2) are three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, middle layer and outer layer. The colorant is blue master batch. The inner layer and outer layer of 3P00B mask are made of spun-bond non-woven fabric, the middle layer is made of Polyethylene Melt-blown non-woven fabric.

    The Disposable Surgical Face Masks (Model: C2900, Level 3) are four-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer, second layer, filtration layer and outer layer. The colorant is blue master batch.

    The inner layer and outer layer of C2900 are made of spun-bonded non-woven fabric, the second layer is made of Polyethylene PE film, the filtration layer is made of Polyethylene Melt-blown non-woven fabric.

    The ear loops of both models are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made with Polyester and spandex. The aluminum nose piece in the layers of face mask is to allow the user to form the mask around their nose.

    The Disposable Surgical Face Masks of both models are sold non-sterile and are intended to be single use, disposable devices.

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