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510(k) Data Aggregation

    K Number
    K212504
    Device Name
    Isolation Gown AAMI Level 3
    Manufacturer
    Kenpax International Limited
    Date Cleared
    2021-11-07

    (90 days)

    Product Code
    FYC
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Isolation Gown AAMI Level 3

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Isolation Gown AAMI Level 3 is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities(ANSI/AAMI PB70). The Isolation Gown is single use, disposable medical device provided non-sterile.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is related to the FDA 510(k) clearance for an "Isolation Gown AAMI Level 3" and primarily concerns regulatory approval. It does not describe a study involving a device with AI or software components that would typically have acceptance criteria presented in the requested format.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving the device meets them, as the provided text pertains to a physical medical device (an isolation gown) and its regulatory clearance based on AAMI Level 3 barrier protection standards, not a software-driven device.

    The information I can extract directly related to performance and standards is:

    Acceptance Criteria for the Isolation Gown AAMI Level 3:

    Acceptance CriteriaReported Device Performance
    Meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70).The device is stated to "meet the requirements of an AAMI Level 3 barrier protection". Specific test results (e.g., impact penetration, hydrostatic pressure according to AAMI PB70) are not detailed in this document but are implied to be satisfactory for clearance.

    The provided document does NOT contain information regarding:

    • Sample size used for the test set or data provenance.
    • Number of experts used to establish ground truth or their qualifications.
    • Adjudication method.
    • MRMC comparative effectiveness study or human reader improvement with AI.
    • Standalone algorithm performance.
    • Type of ground truth used (beyond implying compliance with AAMI PB70 standards, which often involve laboratory testing for physical properties).
    • Sample size for the training set.
    • How ground truth for the training set was established.

    This is because the cleared device is a physical barrier product, not an AI/software as a medical device (SaMD). The assessment for such devices typically involves laboratory testing against established standards (like AAMI PB70) rather than clinical studies with human readers or AI algorithms.

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