BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VR® Personal Protective Level 3 Gown (VR Gowns)

    K Number: K252940 · Decision Dec 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    92

    Basic Information

    Device Name
    VR® Personal Protective Level 3 Gown (VR Gowns)
    K Number
    K252940
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    PolyConversions, Inc.
    Date Received
    September 15, 2025
    Decision Date
    December 16, 2025
    Product Code
    QPC
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

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    Other Clearances by PolyConversions, Inc.

    K Number Device Name
    K230384 PolyWear® Personal Protective Level 3 Gown