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510(k) Data Aggregation

    K Number
    K212661
    Device Name
    Disposable Nitrile Examination Glove
    Manufacturer
    Inner Mongolia Cureguard Medical Technology Co.,Ltd.
    Date Cleared
    2021-11-19

    (88 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 Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

    Device Description

    The subject device is powder free nitrile patient examination gloves. The subject device is white color. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Device: Disposable Nitrile Examination Glove

    1. Table of Acceptance Criteria and Reported Device Performance

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance
    ASTM D6319Physical Dimensions TestLength (mm):XS/S: ≥ 220;M/L/XL: ≥ 230;Width:XS: 70±10;S: 80±10;M: 95±10;L: 105±10;XL: 115±10Length (mm): >230 (all sizes)Width (mm):XS: 73-76;S: 80-83M: 95-97L: 110-114XL: 118-120Pass
    ASTM D6319ThicknessFinger: ≥ 0.05 mmPalm: ≥ 0.05 mmXS:Finger: 0.07-0.11 mmPalm: 0.08-0.10 mmS:Finger: 0.08-0.10 mmPalm: 0.08-0.11 mmM:Finger: 0.08-0.11 mmPalm: 0.08-0.11 mmL:Finger: 0.08-0.12 mmPalm: 0.09-0.12 mmXL:Finger: 0.08-0.12 mmPalm: 0.08-0.11 mmPass
    ASTM D5151Watertightness Test for HolesMeet the requirements of ASTM D5151 AQL 2.5XS: 0/125 leaksS: 0/125 leaksM: 0/125 leaksL: 1/125 leaksXL: 1/125 leaksPass
    ASTM D6124Powder Content< 2.0 mgXS: 0.04 mgS: 0.06 mgM: 0.08 mgL: 0.08 mgXL: 0.09 mgPass
    ASTM D412Physical Properties (Before Aging)Tensile Strength: ≥14 MPaUltimate Elongation: ≥500%XS:Tensile Strength: 15.5-17.9 MPaUltimate Elongation: 524-565%S:Tensile Strength: 16.1-18.1 MPaUltimate Elongation: 520-567%M:Tensile Strength: 15.4-17.9 MPaUltimate Elongation: 528-567%L:Tensile Strength: 15.3-17.7 MPaUltimate Elongation: 521-566%XL:Tensile Strength: 15.4-17.7 MPaUltimate Elongation: 525-567%Pass
    ASTM D412Physical Properties (After Aging)Tensile Strength: ≥14 MPaUltimate Elongation: ≥400%XS:Tensile Strength: 15.3-17.4 MPaUltimate Elongation: 524-568%S:Tensile Strength: 15.4-17.8 MPaUltimate Elongation: 528-563%M:Tensile Strength: 15.5-17.8 MPaUltimate Elongation: 527-570%L:Tensile Strength: 15.5-17.5 MPaUltimate Elongation: 534-563%XL:Tensile Strength: 15.9-17.8 MPaUltimate Elongation: 530-569%Pass
    ISO 10993-5CytotoxicityNon-cytotoxicPass: Under conditions of the study, did not show potential toxicity to L-929 cells.
    ISO 10993-10IrritationNon-irritatingPass: Under the conditions of the study, not an irritant.
    ISO 10993-10SensitizationNon-sensitizingPass: Under conditions of the study, not a sensitizer.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    The sample sizes for some tests are explicitly mentioned:

    • ASTM D5151 (Watertightness Test): 125 gloves per size (XS, S, M, L, XL).
    • Other tests (Physical Dimensions, Thickness, Powder Content, Physical Properties Before/After Aging, Cytotoxicity, Irritation, Sensitization): The exact number of samples tested for each of these is not explicitly stated in the provided text, beyond the aggregated "Results" sections.

    Data Provenance: The document does not specify the country of origin of the testing data or whether the studies were retrospective or prospective. It only states that the testing was "Non-clinical tests." The submitter is Inner Mongolia Cureguard Medical Technology Co., Ltd. from China.

    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 "ground truth" is established by adherence to recognized international and national standards (ISO and ASTM) through laboratory testing, not by expert consensus on diagnostic interpretations.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    Not applicable. This is a non-clinical device performance study based on standardized laboratory testing, not a diagnostic study requiring expert adjudication of results.

    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 device is a medical glove and does not involve AI assistance or human readers.

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

    Not applicable. This device is a medical glove and does not involve an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    The ground truth used for this device is based on pre-defined specifications and limits set by international and national standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10). These standards define acceptable ranges for physical dimensions, strength, elongation, watertightness, powder content, and biocompatibility.

    8. The sample size for the training set

    Not applicable. This is a physical medical device (glove) and does not involve a training set as would be used for machine learning.

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

    Not applicable. This device does not use a training set.

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