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510(k) Data Aggregation

    K Number
    K213844
    Device Name
    Surgical Gown
    Date Cleared
    2023-02-16

    (434 days)

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

    Bayteks Teknik Tekstil San. ve Tic. A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Surgical gowns are intended to be worn by operating room personnel procedure to protect both the surgical patient and the operating room persomel from transfer of microorganisms, body fluids, and particulate material. This device is provided sterile. Per ASNI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the standard (non-reinforced) surgical gowns meet Level 2 classification and the reinforced surgical gowns meet Level 3 classification.
    Device Description
    Surgical gowns are intended to be worn by healthcare professionals to protect both the patient and the healthcare professional from the transfer or microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and ethylene oxide (EO) sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL. The proposed surgical gowns are constructed of a Spunbond (SMS) nonwoven material, with cuffs made of polyester and elastic, offered in standard (non-reinforced) and reinforced surgical gowns, in blue color.
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