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510(k) Data Aggregation

    K Number
    K220333
    Device Name
    Medline Orbis LVL 3 Surgical Gown
    Manufacturer
    Medline Industries, LP.
    Date Cleared
    2022-05-18

    (103 days)

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

    Medline Orbis LVL 3 Surgical Gown

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

    The Medline Orbis LVL 3 Surgical Gown is intended to be worn by healthcare professionals during surgical procedures to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter. The Medline Orbis LVL 3 Surgical Gown is a single use, disposable medical device provided both sterile and nonsterile.

    The Medline Orbis LVL 3 Surgical Gown meets the Level 3 requirements of ANSI/AAMIPB70:2012 Liquid barrier and performance classification of protective apparel and drapes intended for use in healthcare facilities.

    Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization validation to ISO 11135-1.

    Device Description

    The Medline Orbis LVL 3 Surgical Gown is a single use, disposable medical device provided both sterile and nonsterile.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a surgical gown (Medline Orbis LVL 3 Surgical Gown). It states the device's indications for use and confirms its substantial equivalence to a predicate device.

    However, the document does NOT contain information regarding:

    • Acceptance criteria for device performance based on a study. (The text only mentions meeting Level 3 requirements of ANSI/AAMI PB70:2012 for liquid barrier and performance, which is a standard, not specific acceptance criteria from a study).
    • Reported device performance from a specific study.
    • Sample size used for a test set or data provenance.
    • Number of experts or their qualifications for ground truth establishment.
    • Adjudication method for a test set.
    • Multi-reader multi-case (MRMC) comparative effectiveness study.
    • Standalone (algorithm-only) performance.
    • Type of ground truth used (expert consensus, pathology, outcomes data).
    • Sample size for a training set.
    • How ground truth for a training set was established.

    The document is a regulatory clearance letter, not a clinical or performance study report. Therefore, I cannot extract the detailed information requested about acceptance criteria and a study proving those criteria are met.

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