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510(k) Data Aggregation

    K Number
    K211773
    Device Name
    Single-use Surgical Mask
    Date Cleared
    2021-12-02

    (177 days)

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

    Taiwan Seafood and Fish Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Single Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single use device provided non-sterile.
    Device Description
    The Single-Use Surgical Mask is a 3-ply, disposable surgical face mask. The outer and inner layers of the mask are made of spunbond polypropylene, while the middle layer consists of a meltblown polypropylene filter fabric. The device is secured on the user's face via elastic earloops and are labeled non-sterile, single-use, and disposable. This device is a surface device intended to come in contact with intact skin for a duration of less than 24 hours.
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