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510(k) Data Aggregation

    K Number
    K213894
    Device Name
    DWFritz ASM2000
    Date Cleared
    2022-03-14

    (90 days)

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

    DWFritz Automation, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    When properly worn, DWFritz ASM2000 surgical face mask is intended to protect both the patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter. The device is non-sterile and for single use only.
    Device Description
    DWFritz ASM2000 is a 3-ply, flat-pleated style surgical face mask. The device is manufactured with three layers. The inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. Each mask contains ear loops made of polyester filament and spandex fiber to secure the mask over the user's face and mouth with galvanized wire nose bridge to fit firmly over the nose. This device is not made from any natural rubber latex. The product is sold non-sterile and intended to be disposable for single-use.
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