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510(k) Data Aggregation

    K Number
    K230384
    Device Name
    PolyWear® Personal Protective Level 3 Gown
    Manufacturer
    Polyconversions, INC
    Date Cleared
    2023-08-11

    (178 days)

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

    Polyconversions, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PolyWear® Personal Protection Level 3 Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The PolyWear® Personal Protection Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room. The PolyWear® Personal Protection Level 3 Gown meets the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/AAMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70).
    Device Description
    The PolyWear® Personal Protection Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective.
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