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510(k) Data Aggregation

    K Number
    K213625
    Device Name
    Vinyl Examination Gloves
    Manufacturer
    Dezhou Hengchang Medical Technology Co., Ltd.
    Date Cleared
    2022-02-17

    (92 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K180861
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vinyl Examination Glove 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 subject device is powder free vinyl examination gloves. The subject device's color is clear. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for Vinyl Examination Gloves. This is a medical device focused on physical properties and biocompatibility, not an AI/imaging device. Therefore, many of the requested criteria regarding AI model evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone algorithm performance, and ground truth establishment methods) are not applicable to this document.

    However, I can extract the relevant information regarding the device's performance against its acceptance criteria based on the provided non-clinical testing summary.

    Here's the breakdown:

    Acceptance Criteria and Reported Device Performance

    1. Table of Acceptance Criteria and Reported Device Performance

    Test MethodPurposeAcceptance CriteriaReported Device Performance (Results)
    ASTM D5250Physical Dimensions TestLength (mm): S/M/L/XL: ≥230Width (mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5Thickness (mm): Finger: ≥0.08; Palm: ≥0.08Length (mm): > 230 /PassWidth (mm):  S: 81-88 /Pass  M: 90-98/ Pass  L: 100-109/ Pass  XL:110-118/ PassThickness (mm):  Finger: 0.08-0.14/Pass  Palm: 0.08/Pass
    ASTM D5151Watertightness Test for Detection of HolesMeet the requirements of ASTM D5151 (AQL 2.5)0/125 /Pass (Implies 0 failures out of 125 samples, meeting AQL 2.5)
    ASTM D6124Powder ContentMeet the requirements of ASTM D6124 < 2.0mg0.10-0.18mg /Pass
    ASTM D412Physical Properties (Before Aging)Tensile Strength: ≥11MPaUltimate Elongation: ≥300%Tensile Strength: 11-21MPa /PassUltimate Elongation: 300-477% /Pass
    ASTM D412Physical Properties (After Aging)Tensile Strength: ≥11MPaUltimate Elongation: ≥300%Tensile Strength: 11-17MPa /PassUltimate Elongation: 303-412% /Pass
    ISO 10993-5CytotoxicityIn Vitro Cytotoxicity StandardUnder conditions of the study, device extract is cytotoxic. (Note: The acceptance criteria here imply "no cytotoxicity" for "Pass". The document states it is cytotoxic but still lists it as "Pass" somehow, which is contradictory or requires further context from the original submission about acceptable levels of cytotoxicity or if this refers to a specific predicate comparison point not fully detailed in the summary table. Given the overall "Pass" conclusion, it might be that the observed cytotoxicity is within an acceptable range for this specific device type, or mitigated, but the table itself presents a direct contradiction if "In Vitro Cytotoxicity" implies "no cytotoxicity"). Re-evaluating based on the "Pass" in the results column means that despite the wording, it met the defined criteria for "In Vitro Cytotoxicity" for this device. However, the ISO 10993-5 criterion is usually "Non-cytotoxic". This is a point of ambiguity in the provided text.
    ISO 10993-11Systemic 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

    Non-Applicable / Not Provided Information (for this type of device submission)

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

      • Sample Size: For specific tests, sample sizes are sometimes implicitly mentioned (e.g., "0/125" for watertightness), but a general "test set" sample size for overall performance evaluation as would be described for an AI model is not applicable or provided. The testing is per standard procedures for each physical/chemical property.
      • Data Provenance: Not applicable in the same sense as for clinical data. The tests are laboratory-based conformance tests. The manufacturer is Dezhou Hengchang Medical Technology Co., Ltd. from China.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

      • Not applicable. Ground truth for these physical and biocompatibility tests is established by objective measurements and standardized laboratory procedures/protocols, not expert consensus.

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

      • Not applicable. This concept is relevant for subjective evaluations or diagnostic tasks, not for objective material properties testing.

    4. 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 for AI-assisted diagnostic devices.

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

      • Not applicable. This is for AI algorithms.

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

      • The ground truth for this device's performance is based on objective measurements and chemical/biological assays conducted according to internationally recognized standards (ASTM, ISO). For example, a "hole" is objectively defined by the ASTM D5151 test, and tensile strength is measured quantitatively.

    7. The sample size for the training set:

      • Not applicable (no AI/machine learning training involved).

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

      • Not applicable (no AI/machine learning training involved).

    Summary of the Study Proving Acceptance Criteria:

    The study proving the device meets the acceptance criteria is a series of non-clinical performance tests conducted in accordance with recognized international standards. These tests evaluate the physical properties (dimensions, watertightness, powder content, tensile strength, ultimate elongation) and biocompatibility (cytotoxicity, systemic toxicity, irritation, sensitization) of the Vinyl Examination Gloves. The results demonstrate that the device complies with all specified acceptance criteria derived from these standards (ASTM D5250, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10, ISO 10993-11). The conclusion is that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicated device K180861" based on these non-clinical tests. Clinical testing was deemed "not needed for this device."

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