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510(k) Data Aggregation

    K Number
    K080795
    Device Name
    ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN
    Manufacturer
    KIMBERLY-CLARK CORP.
    Date Cleared
    2008-09-03

    (167 days)

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

    ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN

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

    The Kimberly-Clark* ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The ULTRA Surgical Gown meets Level 3 of the AAMI Liquid Barrier classifications, and the ULTRA Film-Reinforced Surgical Gown meets Level 4 of the AAMI Liquid Barrier classifications.

    Device Description

    The ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown are full-length, nonwoven SMS polypropylene gowns. They are constructed with raglan sleeves, hook-and-loop neck closures, and tie waist closures. The ULTRA Film-Reinforced Surgical Gown is film-reinforced for higher barrier protection. The ULTRA Surgical Gown fully meets the Association for the Advancement of Medical Instrumentation (AAMI) Level 3 requirements for liquid barrier performance. The ULTRA Film-Reinforced Surgical Gown fully meets the AAMI Level 4 requirements for liquid barrier performance.

    AI/ML Overview

    This is not an AI/ML device, and therefore, the requested information is not applicable. This 510(k) pertains to a physical medical device (surgical gowns) and its performance in meeting liquid barrier standards. The questions are designed for AI/ML-driven diagnostic or prognostic tools that involve data analysis and human readers.

    However, I can provide a summary of the acceptance criteria and how the device meets them based on the provided text:

    Description of Acceptance Criteria and Device Performance

    The Kimberly-Clark ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown are sterile, single-use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

    The acceptance criteria for these devices are based on established industry standards for liquid barrier performance and other safety attributes.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaStandard/RequirementDevice Performance (ULTRA Surgical Gown)Device Performance (ULTRA Film-Reinforced Surgical Gown)
    Liquid Barrier PerformanceANSI/AAMI PB70: 2003 Level 3Meets Level 3 requirementsN/A
    Liquid Barrier PerformanceANSI/AAMI PB70: 2003 Level 4N/AMeets Level 4 requirements
    FlammabilityNFPA Test Method 702-1980Meets Class I requirementsMeets Class I requirements
    BiocompatibilityISO 10993 for surface devices with limited contact with breached or compromised surfacesMeets biocompatibility requirementsMeets biocompatibility requirements

    Study Proving Device Meets Acceptance Criteria:

    The device's performance against the acceptance criteria was demonstrated through a series of tests as summarized in the "Summary of Testing" section.

    • Liquid Barrier Performance:

      • The ULTRA Surgical Gown was tested in compliance with the Level 3 liquid barrier performance requirements of ANSI/AAMI PB70: 2003. The submission states it "fully meets the AAMI Level 3 requirements."
      • The ULTRA Film-Reinforced Surgical Gown was tested in compliance with the Level 4 liquid barrier performance requirements of ANSI/AAMI PB70: 2003. The submission states it "fully meets the AAMI Level 4 requirements."

    • Flammability: Both the ULTRA Surgical Gown and ULTRA Film-Reinforced Surgical Gown were tested in compliance with the requirements of the National Fire Protection Association (NFPA) Test Method 702-1980 for Class I.

    • Biocompatibility: Both gowns were tested in compliance with the biocompatibility requirements of ISO 10993 for surface devices with limited contact with breached or compromised surfaces.

    Regarding the AI/ML-specific questions (2-9), these are not applicable to this 510(k) submission for surgical gowns:

    1. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI/ML model utilizing a test set.
    2. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for a physical product's performance is established by standardized testing protocols, not expert consensus on data.
    3. Adjudication method: Not applicable.
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This type of study is for evaluating human performance with or without AI assistance, which is not relevant here.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    6. The type of ground truth used: For this device, the "ground truth" is defined by the performance standards outlined in ANSI/AAMI PB70: 2003, NFPA Test Method 702-1980, and ISO 10993, which involve laboratory testing methodologies.
    7. The sample size for the training set: Not applicable. There is no training set for a physical surgical gown.
    8. How the ground truth for the training set was established: Not applicable.
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