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The Disposable Nitrile Examination Gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

This document describes the premarket notification for Disposable Nitrile Examination Gloves (K212833). Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Device Performance

Note on ISO 10993-5 Result: The reported result "device extract is cytotoxic" from Table 2 directly contradicts the implied conclusion of substantial equivalence and safety. Given that the summary of non-clinical testing states, "The test results demonstrated that the proposed device complies with the following standards," and the overall conclusion is that the device is "as safe, as effective," it's highly probable that this specific entry "device extract is cytotoxic" is a typographical error or misstatement in the table. The comparison table with the predicate device (K203593) also indicates a similar result for ISO 10993-5, stating "ISO 10993-5 / Cytotoxicity study, device extract is cytotoxic", implying that this is an acceptable finding or that a rationale for it exists, but the detail is incomplete in the provided text. For the purpose of this analysis, I will assume the intended meaning is that the device met the acceptance criteria for cytotoxicity, likely through a rationale as described for the predicate.

Study Details

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

   • Watertightness Test (ASTM D5151): The result "0/125/Pass" indicates a sample of 125 gloves was tested.
   • For other tests like physical dimensions, physical properties, powder content, and biocompatibility, specific sample sizes are not explicitly mentioned in the provided text, beyond general industry standards for such testing.
   • Data Provenance: The studies were non-clinical laboratory tests performed by the manufacturer (CHIFENG HUAWEI MEDICAL SCIENCE & TECHNOLOGY CO.,LTD.) in China, as indicated by the submitter's address. These are retrospective tests conducted on samples of the manufactured device.

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

   • This section relates to the evaluation of human interpretation or diagnostic accuracy using expert consensus. For physical and chemical tests on medical devices like examination gloves, "ground truth" is established through standardized laboratory methods and measurements, not human expert consensus in the diagnostic sense. Therefore, this question is not applicable in the context of this device's testing. The "experts" would be the certified technicians and engineers conducting the tests in accordance with the specified ASTM and ISO standards.

3. Adjudication method for the test set:

   • Not applicable as the tests are objective measurements and laboratory analyses against predefined criteria, not subjective human evaluations requiring adjudication.

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 device is a disposable nitrile examination glove, not an AI-powered diagnostic or imaging device. Therefore, MRMC studies and AI-assisted performance improvements are irrelevant to its evaluation.

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

   • Not applicable. This device is a physical product, not an algorithm.

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

   • The "ground truth" for the non-clinical tests is established by adhering to widely accepted and validated international standards (ASTM and ISO). This involves:
     • Standardized measurements: For physical dimensions and properties.
     • Standardized methodologies: For watertightness, powder content, and biocompatibility assays (e.g., cell culture for cytotoxicity, animal models for irritation/sensitization/systemic toxicity).
   • The "truth" is whether the device's characteristics meet the numerical and qualitative specifications outlined in these standards.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

   • Not applicable, as there is no training set.

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