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510(k) Data Aggregation

    K Number
    K242689
    Device Name
    AAMI Level 4 Protective; Gown
    Manufacturer
    AZAC Group
    Date Cleared
    2025-01-13

    (129 days)

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

    AZAC Group

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AAMI Level 4 Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The AAMI Level 4 Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012 - Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities; but has an open back which is non-protective. The AAMI Level 4 Protective Gown is a single use, disposable medical device and is provided non-sterile.
    Device Description
    The AAMI Level 4 Protective Gown is a single use, disposable medical device and is provided non-sterile. It has an open back which is non-protective.
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    K Number
    K211538
    Device Name
    Protect X Level 3 Isolation Gown
    Manufacturer
    AZAC Group
    Date Cleared
    2021-11-17

    (183 days)

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

    AZAC Group

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown gown meets the barrier protection requirements of AAMI Level 3 per ANSI/AAMI PB70:2012 – Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is a single use, disposable medical device and is provided non-sterile.
    Device Description
    The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is used in moderate risk situations such as venous blood draws, inserting IVs, and emergency room use. The gown is not sterile; is not an isolation gown and is not indicated for use in the Operating Room. The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is made of one-piece chlorinated polyethylene elastomer non-woven tri-laminate. The Level 3 gown meets the ANSI/ AAMI PB70 Level 3 standards. The gown is a single use, disposable device.
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