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510(k) Data Aggregation

    K Number
    K210222
    Device Name
    Disposable Medical Mask
    Date Cleared
    2021-11-02

    (278 days)

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

    Guangdong Lide Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The surgical face masks (Ear loops) are 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 the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
    Device Description
    The Surgical Face Mask are Non-sterile, single use, 3 layers, flat-pleated style with mask belt and nose clip. The outer layer and inner facing layer of face mask consist of spunbond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains mask belt to secure the mask over the user's face and mouth with nose clip to firmly fit over the nose. This device is not made from any natural rubber latex.
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