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510(k) Data Aggregation

    K Number
    K214094
    Device Name
    ROKI Surgical Mask
    Manufacturer
    Date Cleared
    2022-02-24

    (58 days)

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

    ROKI Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ROKI 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. The ROKI Surgical 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, provided non-sterile. Model: L and M, white color, and Level 3 barrier level per ASTM F2100-19.
    Device Description
    The subject device is white color, and flat pleated type mask, utilizing ear loops' way for wearing, and has nose fitter design for fitting the facemask around the nose. The subject device is consisted of three layers, the inner and outer layers are made with spun-bond polypropylene, and the middle laver is made with melt blown polypropylene. The subject device is held in place over the user's mouth and nose by two elastic ear loops welded to the mask. The elastic ear loops are made with polyester and polyurethane. The nose fitter contained in the subject device is in the layers of the mask to allow the user to fit the mask around their nose, which is made of malleable aluminum wire. There are two models of the subject device, Model M. They differ only in the width. Model L is wider than Model M. However, the material formulation, chemical composition, and material 's processing methods are the same. The subject device is a single-use, disposable device, provided non-sterile. The performance of the subject device meets Level 3 requirements per ASTM F2100-19.
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