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510(k) Data Aggregation

    K Number
    K202845
    Device Name
    Bodygard SFS Surgical Gown Level 3
    Date Cleared
    2022-02-24

    (517 days)

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

    Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bodygard SFS Surgical Gown Level 3 is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Bodygard SFS Surgical Gown Level 3 met the requirements for Level 3 classification.
    Device Description
    The Bodygard SFS Surgical Gown Level 3 is a poly reinforced surgical gown, SMS Nonwoven/Film/SMS Nonwoven (SFS) that provides AAMI Level 3 liquid barrier protection in the critical zones (arms and chest) and non-critical zones of the gown. The Bodygard SFS Surgical Gown Level 3 is manufactured using ultrasonic bonding technique and are available in four different sizes (M, L, XL, and XXL). Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The Bodygard SFS Surgical Gown Level 3, meets the requirements for Level 3 classification, are disposable medical devices and provided in sterile.
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    K Number
    K212111
    Device Name
    Myflon Surgical Mask Level 3
    Date Cleared
    2022-01-23

    (201 days)

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

    Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Myflon Surgical Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face 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.
    Device Description
    The Myflon Surgical Mask Level 3 is blue in color, composed of three-layers, a flat-pleated type mask, utilizing ear loops for wearing. The Myflon Surgical Mask Level 3 materials consist of an outer cover (polypropylene spunbond, blue), middle filtration layer (polypropylene, melt-blown, white), and inner cover comfort/support layer web (polypropylene spunbond, white). Each mask has stretchable elastic laminate (Spunbond/elastic film/spunbond bond) ear loops to secure the mask over the user's mouth and nose and includes a polyethylene/ polypropylene coated wire nosepiece to provide a firm fit over the face and nose. This face mask is a single use, disposable device, provided non-sterile. This device is not made with natural rubber latex.
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