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510(k) Data Aggregation

    K Number
    K211762
    Device Name
    Altor Safety 4-Ply Surgical Mask (Model:62232)
    Manufacturer
    Date Cleared
    2021-09-03

    (87 days)

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

    Altor Safety LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Altor Safety 4-Ply Surgical Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 4-Ply 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, non- sterile, disposable device.
    Device Description
    The Altor Safety 4-Ply Surgical Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The mask outward facing layer is blue in color, using color master batch. The device is manufactured with 4 layers: 2-Outer Facing Layers: Spunbond nonwoven polypropylene (Blue), Middle Layer: Melt Blown nonwoven polypropylene (White) and Inner Layer: Spunbond nonwoven polypropylene (White). Other Materials used include the Ear loops which are made from Spandex / Nylon. The subject device is provided non-sterile and is a single use, disposable device.
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    K Number
    K211249
    Device Name
    Altor Safety 3-Ply Surgical Mask (Model:62222)
    Manufacturer
    Date Cleared
    2021-07-23

    (88 days)

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

    Altor Safety LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Altor Safety 3-Ply Surgical Mask (Model:62222) is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 3-Ply 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, non-sterile, disposable device.
    Device Description
    The Altor Safety 3-Ply Surgical Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The mask outward facing layer is blue in color, using color master batch. The product model number of the subject device is : 62222. The ASTM Level of the subject device is ASTM Level 2. The subject device is manufactured with three layers: Outer Layer: Spunbond nonwoven polypropylene, Middle Layer: Melt Blown nonwoven polypropylene, Inner Layer: Spunbond nonwoven polypropylene. The subject device is provided non-sterile and is a single use, disposable device.
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