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510(k) Data Aggregation

    K Number
    K213662
    Device Name
    Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)
    Manufacturer
    Taishan Weibang Medical Equipment Co., Ltd.
    Date Cleared
    2022-03-28

    (126 days)

    Product Code
    LZA,LZC
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K190860
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

    Device Description

    The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large. The subject device is non-sterile.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study that proves the device, Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs), meets those criteria.

    Here's the information extracted and formatted as requested:

    1. Table of acceptance criteria and the reported device performance:

    Test MethodPurposeAcceptance CriteriaReported Device Performance
    ASTM D6319Physical Dimensions TestLength (mm): S:≥220; M/L/XL:≥230; Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10; Thickness (mm): Finger: ≥0.05; Palm: ≥0.05Length (mm): ≥ 230/Pass; Width (mm): S: 85-89 /Pass; M: 94-97/ Pass; L: 100-104/ Pass; XL:110-113/ Pass; Thickness (mm): Finger: 0.16-0.18/Pass; Palm: 0.11-0.12/Pass
    ASTM D5151Watertightness Test for Detection of HolesMeet the requirements of ASTM D5151 AQL 2.50/125/Pass
    ASTM D6124Powder ContentMeet the requirements of ASTM D6124 2.0mg0.15-0.19mg/Pass
    ASTM D412Physical properties (Tensile Strength)Before Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥500%; After Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥400%Before Aging: 16.5-33.1MPa/Pass; 500-585%/Pass; After Aging: 14.1-28.3MPa/Pass; 482-555%/Pass
    ISO 10993-5CytotoxicityNon-cytotoxicUnder conditions of the study, device extract is cytotoxic (Note: This is a discrepancy identified in the document, but the device was still cleared based on other testing)
    ISO 10993-11Acute systemic toxicityNon-acute systemic toxicityUnder conditions of the study, did not show acute systemic toxicity in vivo / Pass
    ISO 10993-10IrritationNon-irritatingUnder the conditions of the study, not an irritant/ Pass
    ISO 10993-10SensitizationNon-sensitizingUnder conditions of the study, not a sensitizer./ Pass
    ASTM D6978-05Chemotherapy Drug Permeation (Breakthrough Detection Time)-Carmustine (BCNU) 3.3 mg/ml: 33.5 Minutes; Cisplatin 1.0 mg/ml: > 240 Minutes; Cyclophosphamide 20.0 mg/ml: > 240 Minutes; Dacarbazine 10.0 mg/ml: > 240 Minutes; Doxorubicin HCl 2.0 mg/ml: > 240 Minutes; Etoposide 20.0 mg/ml: > 240 Minutes; Fluorouracil 50.0 mg/ml: > 240 Minutes; Paclitaxel 6.0 mg/ml: >240 Minutes; Thio Tepa 10.0 mg/ml: 62.6 Minutes. Warning: Please do not use with Carmustine (BCNU) and Thiotepa.

    2. Sample size used for the test set and the data provenance:

    • Sample size for Watertightness Test (ASTM D5151): 125 gloves (indicated by "0/125/Pass").
    • Data provenance: Not explicitly stated, but based on the context of a 510(k) submission, this would be data generated by the manufacturer from laboratory testing (bench testing) of their product. It is inherently retrospective as the testing precedes the submission.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. This device is a medical glove, and the acceptance criteria are based on standardized physical and chemical performance tests rather than expert interpretation of medical images or patient data. The "ground truth" is defined by the objective measurements and pass/fail criteria of the ASTM and ISO standards.

    4. Adjudication method for the test set:

    • Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring expert adjudication.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • Not applicable. This is not an AI-powered diagnostic device, but a medical glove. MRMC studies are used for evaluating diagnostic performance with and without AI assistance for human readers of medical images.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This is not an AI algorithm.

    7. The type of ground truth used:

    • The ground truth is established by objective measurements against established international standards (ASTM and ISO) for physical properties, barrier integrity, biocompatibility, and chemical permeation.

    8. The sample size for the training set:

    • Not applicable. This is not a machine learning or AI device that requires a training set.

    9. How the ground truth for the training set was established:

    • Not applicable. No training set is used for this device.
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