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510(k) Data Aggregation

    K Number
    K211497
    Device Name
    Surgical Mask
    Date Cleared
    2021-07-28

    (75 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Honeywell Safety Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Honeywell Procedure Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
    Device Description
    The Honeywell Procedure Mask is composed of three layers that are a flat, pleated style mask with earloops to secure it over the users' mouth and face. The inner and outer layers are manufactured from spun-bond polypropylene. The middle layer is made of melt-blown polypropylene. The mask is a single use, disposable device, provided nonsterile and is not made from natural rubber latex.
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