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510(k) Data Aggregation

    K Number
    K252650

    Validate with FDA (Live)

    Date Cleared
    2026-01-05

    (136 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 Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical Face Mask is 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 Disposable Medical Face Mask is single use, three-layer, 3-pleated or 4-pleated flat-folded masks with nose piece and ear loops or ties. The masks will be provided in blue or black color with option for a visor. The colorant is polypropylene (PP) master batch.

    The body of the mask is composed of three layers: the inner and outer layers are made of spun-bond polypropylene, the 2nd layer is made of melt blown polypropylene. The only difference between Level 1, Level 2, and Level 3 masks is the material density in the middle layer. The nose piece is made of Iron wire covered with polypropylene plastic, ear loop is made of elastic band, the ties are made of spun-bond polypropylene, and the visor is made of polyethylene terephthalate (PET).

    Each mask contains ear loops or ties to secure the mask over the user's face and mouth with a bendable nose piece to firmly fit over the nose. This device is not made with natural rubber latex.

    The disposable medical face masks are sold non-sterile and are intended to be single use, disposable devices.

    AI/ML Overview

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