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510(k) Data Aggregation

    K Number
    K212311
    Device Name
    Medical Examination Gloves
    Manufacturer
    Guangzhou Junda Gloves Co., Ltd
    Date Cleared
    2021-10-21

    (90 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K171422
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medical Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.

    Device Description

    The proposed device is Powder Free Medical Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Medical Examination Gloves, based on the provided FDA 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance CriteriaReported Device Performance
    Biocompatibility - Skin Sensitization (ISO 10993-10)Provided grades less than 1, otherwise sensitization.All grades are 0. All animals survived and no abnormal signs were observed during the study.
    Biocompatibility - Skin Irritation (ISO 10993-10)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.
    Biocompatibility - In Vitro Cytotoxicity (ISO 10993-5)Viability reduced to
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