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510(k) Data Aggregation

    K Number
    K212812
    Device Name
    Surgical Gown
    Date Cleared
    2022-11-16

    (439 days)

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

    Xianning Marveldas Protective Articles CO.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Surgical gowns are sterile, disposable, and single use devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. This device is sterilized using Ethylene Oxide (EO) following the Validation and routine control under ANSI/AAMI/ISO 11135 (2014).
    Device Description
    The Sterile Level 4 Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use and EO sterilized. The Sterile Level 4 Surgical Gowns are available in five models including S、 M、L、XL and XXL. The proposed surgical are constructed of a SMS nonwoven material (SMS+Film covering material+Velcro tape+Cuff material) and it is a kind of reinforced surgical gown and blue color.
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