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510(k) Data Aggregation

    K Number
    K221559
    Device Name
    Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3
    Manufacturer
    StringKing
    Date Cleared
    2023-02-23

    (268 days)

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

    StringKing

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StringKing Disposable Surgical Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. The StringKing Surgical Gowns meet Level 3 and Level 4 requirements of ANSI/AAMI PB 70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
    Device Description
    The Disposable Surgical Gown consists of a multi-layer nonwoven spunbond-meltblownspunbond (SMS) polyolefin & Film Lamination in the critical zones and a single layer of lighter, more breathable nonwoven SMS polvolefin in the non-critical zones. The StringKing Disposable Surgical Gown is designed for easy donning and doffing with hook and loop neck tabs, belt ties, removable transfer accessory, and polyester wrist cuffs. The StringKing Disposable Surgical Gown is one gown design that meets both Level 4 requirements of AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The gown will be marketed as a L3 gown as well as a L4 gown. The StringKing Disposable Surgical Gowns are single use, disposable medical devices that will be provided sterile.
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