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510(k) Data Aggregation

    K Number
    K211229
    Device Name
    Vinyl compound examination gloves
    Manufacturer
    Hebei Titans Hongsen Medical Technology Co., LTD.
    Date Cleared
    2021-07-29

    (97 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K182043
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vinyl compound examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

    Device Description

    The proposed device, Vinyl compound examination gloves are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is Blue. The design of proposed device is addressing the standards as ASTM D6124. ASTM D5151, and ASTM D5250. The proposed device is not provided as sterilized. The proposed device is made of vinyl chloride.

    AI/ML Overview

    This document is a 510(k) premarket notification for "Vinyl compound examination gloves." It focuses on demonstrating substantial equivalence to a predicate device, not on proving new clinical effectiveness or diagnostic accuracy of an AI device. Therefore, many of the requested categories related to AI studies, ground truth, expert adjudication, and comparative effectiveness are not applicable.

    Here's an analysis based on the provided text, focusing on the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test MethodPurposeAcceptance Criteria (from D5250)Reported Device Performance
    ASTM D5151Testing for Freedom from holesFreedom from holesNo water leakage is inspected from 200 samples
    ASTM D6124Determine the powder residue for powder free gloves<2.0 mg per gloveResidual Powder of Size XS: Average 0.28 mg;Residual Powder of Size S: Average 0.25 mg;Residual Powder of Size M: Average 0.31 mg;Residual Powder of Size L: Average 0.25 mg;Residual Powder of Size XL: Average 0.35mg;
    ASTM D412, ASTM D573Testing for Physical property characteristicsTensile Strength: 11 MPa min.Ultimate Elongation: 300% min.Tensile Strength: ≥ 12 MPa;Ultimate Elongation: ≥ 321%.
    ASTM D3767Testing For physical dimensions specificationLength: 230 mm min. for all sizes (XS, S, M, L, XL);Width: 75±5 mm for XS; 85±5 mm for S;95±5 mm for M; 105±5 mm for L; 115±5 mm for XL.Finger Thickness: ≥0.08 mm;Palm Thickness: ≥0.08 mm;All acceptance criteria above meet the requirements in Table 2 Dimensions and Tolerances of ASTM D5250Length of Size XS: ≥ 237 mm;Width of Size XS: 75±1 (74-76) mm;Palm Thickness of Size XS: ≥0.08 mm;Finger Thickness of Size XS: ≥0.09 mm.Length of Size S: ≥ 235 mm;Width of Size S: 85±1 (85-86) mm;Palm Thickness of Size S: ≥0.08 mm;Finger Thickness of Size S: ≥0.09 mm.Length of Size M: ≥ 235 mm;Width of Size M: 95±2 (95-97) mm;Palm Thickness of Size M: ≥0.08 mm;Finger Thickness of Size M: ≥0.09 mm.Length of Size L: ≥ 235 mm;Width of Size L: 105±2 (105-107) mm;Palm Thickness of Size L: ≥0.08 mm;Finger Thickness of Size L: ≥0.09 mm.Length of Size XL: ≥ 234 mm;Width of Size XL: 115±3 (115-118) mm;Palm Thickness of Size XL: ≥0.08 mm;Finger Thickness of Size XL: ≥0.09 mm.
    ISO 10993-5Evaluate the endpoint of Cytotoxicity for biocompatibilityThe test article showed "negative" cytotoxicityUnder the conditions of the study, the test article showed "negative" cytotoxicity.
    ISO 10993-10 (Irritant)Evaluate the endpoint of irritant for biocompatibilityThe response of the test article extract is negligible.The test result showed that the response of the test article extract was categorized as negligible under the test condition.
    ISO 10993-10 (Sensitization)Evaluate the endpoint of sensitization for biocompatibilityThe test article showed no evidence of causing delayed dermal contact sensitization.The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.

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

    • ASTM D5151 (Freedom from holes): 200 samples. The data provenance is not specified beyond being "bench tests conducted." Given the company location (China), it's likely the tests were conducted in China. It is a prospective test, as it's part of the device's design verification.
    • Other tests (D6124, D412, D573, D3767, ISO 10993-5, ISO 10993-10): Specific sample sizes for each characteristic within these tests are not explicitly stated, but the results are reported as averages or meeting minimums across sizes. It is implied that adequate samples per standard test method were used. Data provenance is similar to D5151.

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

    • Not Applicable. This document describes safety and performance testing for a physical medical device (gloves) against established international standards (ASTM, ISO). There is no "ground truth" derived from expert interpretation (like medical image analysis) involved in these non-clinical tests. The tests themselves provide objective measurements against defined criteria.

    4. Adjudication method for the test set

    • Not Applicable. As mentioned above, these are objective physical and chemical tests, not involving human interpretation or adjudication. The results are quantitative measurements against predefined thresholds.

    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 device, and therefore, no MRMC study or AI assistance evaluation was performed.

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

    • Not Applicable. This is not an AI device.

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

    • Standardized Test Methods and Criteria: The "ground truth" for these tests are the objective, pre-defined acceptance criteria specified by the relevant international standards (ASTM D5250, D5151, D6124, ISO 10993-5, ISO 10993-10). These standards themselves represent a consensus of expert knowledge in materials science, medical device design, and biocompatibility, but not in the context of diagnostic interpretation.

    8. The sample size for the training set

    • Not Applicable. This is not an AI device.

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

    • Not Applicable. This is not an AI device.
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