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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 <70% of the blank indicates cytotoxic potential.Viability of 100% test article extract is 38.4%. (Indicating potential cytotoxicity to L-929 cells in the MTT method).
    Biocompatibility - Systemic Toxicity (ISO 10993-11)Within the monitoring period (72 h), if the toxicosis response of testing group is not greater than that of control group, the testing sample is regarded as acceptable.No toxicosis response in testing group. (Meaning no potential acute systemic toxicity on ICR mice in the extraction method).
    Residual Powder (ASTM D6124)Powder residue limit of 2.0 mg/glove.0.11 mg /glove.
    Freedom from Holes (ASTM D5151)Samples number: 125 gloves. AQL: 2.5 (ISO 2859). Criterion ≤7 gloves for water leakage.No glove water leakage found.
    Dimensions (ASTM D6319)S: width 80±10mm, Length ≥220 mmM: width 95±10mm, Length ≥230 mmL: width 110±10mm, Length ≥230 mmXL: width 120±10mm, Length ≥230 mmThickness: Finger ≥0.05 mm, Palm ≥0.05 mmS: width: 84-87 mm, Length 239-242 mmM: width 95-97 mm, Length 243-245 mmL: width 104-106 mm, Length 250-252 mmXL: width 114-117 mm, Length 244-247 mmThickness: Finger 0.09 mm, Palm 0.07 mm
    Physical Properties - Before Aging (ASTM D6319)Tensile strength ≥ 14MPaUltimate Elongation ≥ 500%Tensile strength 14.06-20.59 MPaUltimate Elongation 552.680% - 652.080%
    Physical Properties - After Accelerated Aging (ASTM D6319)Tensile strength ≥ 14MPaUltimate Elongation ≥ 400%Tensile strength 14.06-16.90MPaUltimate Elongation 508.43% - 646.33%

    2. Sample Sizes and Data Provenance

    • Freedom from Holes (ASTM D5151): The sample size used for the test set was 125 gloves. The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned. However, typically such testing is prospective and conducted at the manufacturer's facility or a certified lab.
    • For other tests (Biocompatibility, Residual Powder, Dimensions, Physical Properties), specific sample sizes for each test are not provided in the summary. They generally fall under the methodologies prescribed by the respective ASTM/ISO standards.
    • Data Provenance: The document does not specify the country of origin for the data (e.g., test samples) or if the studies were retrospective or prospective. Given that this is a 510(k) summary for a premarket notification, the testing would generally be prospective to demonstrate compliance with standards for the device being submitted.

    3. Number of Experts and Qualifications for Ground Truth

    • This device is a medical examination glove, which is a Class I device. The testing outlined focuses on physical properties, chemical properties (biocompatibility), and manufacturing quality (freedom from holes, powder content).
    • No "experts" in the traditional sense (e.g., radiologists) were used to establish ground truth in the context of image interpretation or complex clinical diagnoses. The ground truth for these tests is based on objective measurements and established scientific protocols (e.g., chemical analysis, physical property testing, biological assays) as defined by the referenced ISO and ASTM standards. The "truth" is determined by the outcome of these standardized tests against predefined limits.

    4. Adjudication Method for the Test Set

    • Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, particularly for diagnostic devices where multiple human readers or a consensus of experts is needed to establish a "ground truth" for ambiguous cases.
    • For these gloves, the acceptance criteria are based on objective, quantifiable measurements or qualitative observations by trained laboratory personnel following standard operating procedures. There is no human interpretation or diagnostic "adjudication" necessary.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No. This type of study is not relevant for a medical examination glove. MRMC studies are used for diagnostic devices, particularly AI-powered ones, to compare the performance of human readers with and without AI assistance on a set of clinical cases.
    • Medical examination gloves are physical barriers, and their effectiveness is evaluated by their material properties, barrier integrity, and biocompatibility, not by their influence on human reading or diagnostic accuracy.

    6. Standalone (Algorithm Only) Performance Study

    • No. This concept is not applicable. A "standalone" study refers to the performance of an algorithm (AI) without any human interaction. Medical examination gloves do not involve algorithms or AI. The device is a physical product.

    7. Type of Ground Truth Used

    • The ground truth used for the tests is derived from:
      • Objective measurement standards: For dimensions, physical properties (tensile strength, elongation), and powder content, the ground truth is an objective, quantitative measurement against the limits specified in ASTM D6319 and ASTM D6124.
      • Biological assay outcomes: For biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity), the ground truth is the biological response (or lack thereof) observed in in vitro or in vivo models, interpreted according to the criteria defined in ISO 10993 series.
      • Absence of defect: For "freedom from holes," the ground truth is the absence of water leakage, as determined by ASTM D5151.

    8. Sample Size for the Training Set

    • Not applicable. Medical examination gloves are not "trained" in the sense of machine learning algorithms. There is no training set for this device. The physical gloves are manufactured and then tested to ensure they meet specified standards.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable. As there is no training set for this device, the question of how its ground truth was established is irrelevant.
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