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510(k) Data Aggregation

    K Number
    K230304
    Device Name
    Polyisoprene Surgical Gloves
    Manufacturer
    Puyang Linshi Medical Supplies Co., Ltd.
    Date Cleared
    2023-08-09

    (187 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K171047
    Why did this record match?
    Reference Devices :

    K171047

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

    The Polyisoprene Surgical Gloves are sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.

    Device Description

    The proposed device is Polyisoprene Surgical Gloves, sterile and disposable devices. The proposed devices are made of polyisoprene. The proposed device is white. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D3577.

    AI/ML Overview

    The provided document is a 510(k) summary for Polyisoprene Surgical Gloves, which are a Class I medical device. The document does not describe an AI/ML-enabled device or an diagnostic device requiring an MRMC study or AI-specific acceptance criteria.

    The acceptance criteria provided in the document relate to the physical and biological characteristics of the surgical gloves as per various ASTM and ISO standards, and the "study" is a series of non-clinical performance tests confirming the gloves meet these established standards.

    Therefore, I cannot extract information related to AI/ML device performance, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or training set details as these are not relevant to the product described in the input.

    However, I can extract the acceptance criteria and performance data for the Polyisoprene Surgical Gloves as presented in the document.

    Acceptance Criteria and Reported Device Performance (for Polyisoprene Surgical Gloves)

    1. Table of Acceptance Criteria and Reported Device Performance

    No.Name of the Test Methodology / StandardPurposeAcceptance CriteriaReported Device Performance
    1ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Skin Sensitization.Assesses possible contact hazards released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization.Skin Sensitization Test: provided grades less than 1, otherwise sensitization.All grades are 0. All animals were survived, and no abnormal signs were observed during the study.
    2ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritationAssesses possible contact hazards released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization.Skin Irritation Test: If the primary irritation index is 0-0.4, the response category is Negligible. 0.5-1.9 means slight, 2-4.9 means moderate, 5-8 means severe.The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition.
    3ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro CytotoxicityDescribes test methods to assess the in vitro cytotoxicity of medical devices.The viab.% of the 100% extract of the test article is the final result, and if viability is reduced to 24 h
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