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    K Number
    K251902
    Device Name
    Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)
    Manufacturer
    Vitacore Industries Inc.
    Date Cleared
    2025-09-17

    (89 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K220670,K191355
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Vitaform Procedural Masks are intended to be worn to protect both the patient and the healthcare worker from transfer of microorganisms, body fluids, and particulate material. They are single-use and intended for use in infection control practices to reduce potential exposure to blood and body fluids.

    Device Description

    Vitaform Procedural Mask (henceforth referred to as "Vitaform")

    The Vitaform Procedural Mask is a single-use, three-layered, fish-shaped surgical mask with ear loops and an aluminum nose piece. The inner and outer layers are made of spunbond polypropylene, and the middle filter layer consists of meltblown polypropylene. The ear loops are made of PET and Spandex material, and worn around the ears to keep the mask close to the face. The nose piece is a flexible aluminum strip that is fitted over the nose so that the mask conforms better to the user's face.

    The Vitaform Procedural Mask is provided in the color blue. It is non-sterile and intended to be a single-use, disposable medical device.

    Vitaform Procedural Mask with Shield (henceforth referred to as "Vitaform-FS")

    The Vitaform Procedural Mask with Shield is a single-use, fish-shaped surgical mask with ear loops and an aluminum nose piece. The inner and outer layers are made of spunbond polypropylene, and the middle filter layer consists of meltblown polypropylene. The insertion layer that provides structural support is made of thermal-bonded polypropylene. The ear loops are made of PET and Spandex material, and is worn around the ears to keep the mask close to the face. The nose piece is a flexible aluminum strip that is fitted over the nose so that the mask conforms better to the user's face. The mask also contains a face shield (FS) made from a polyethylene terephthalate film, and an anti-reflective flap. The face shield is welded to the upper half of the mask to cover the upper part of the face.

    The Vitaform Procedural Mask with Shield is provided in the color blue. It is non-sterile and intended to be a single-use, disposable medical device.

    AI/ML Overview

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