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The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue is a single-use disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue is a class I medical device classified under Product Code LZA. It is a single-use disposable device that meets all requirements of ASTM D 6319-10.

The Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue were evaluated for substantial equivalence based on a comparison to a predicate device and adherence to recognized consensus standards. The study demonstrates the device meets the acceptance criteria through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each test within the ASTM and ISO standards. However, the tests were "non-clinical testing" as indicated by "Summary of Non-clinical Testing Data." The provenance of the data is from the manufacturer's testing of their product, Koon Seng SDN. BHD., located in Tangkak, Johor, Malaysia. The testing is reported retrospectively as part of the 510(k) submission.

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

This information is not explicitly provided in the document. For these types of glove tests, the "ground truth" is typically established by the standardized methods and criteria defined within the ASTM and ISO standards themselves, rather than through expert consensus in the same way clinical diagnostic studies would. The testing would be performed by qualified laboratory personnel following these established protocols.

4. Adjudication method for the test set:

Adjudication methods like 2+1 or 3+1 are not applicable here. The evaluation involves standardized laboratory tests against predefined physical and chemical specifications in the ASTM and ISO standards. The results of these tests are objectively measured and compared directly to the passing criteria within the standards.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging or AI-assisted clinical decision-making devices, not for patient examination gloves. The evaluation of these gloves focuses on physical and biological material properties and performance.

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

This is not applicable as the device is a medical device (examination gloves), not an algorithm or AI system. The performance evaluated is the physical properties and biocompatibility of the gloves themselves, not a standalone algorithm.

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

The "ground truth" for the device's performance is established by the specified requirements and testing methodologies outlined in the referenced FDA-recognized consensus standards: ASTM D3578-05, ASTM D6124-06, ASTM D6319-10, and ISO 10993-10. These standards define the acceptable performance characteristics (e.g., tensile strength, elongation, barrier integrity, residual powder, biocompatibility) that the gloves must meet.

8. The sample size for the training set:

This is not applicable, as there is no training set for a physical medical device like examination gloves. Training sets are used in the context of machine learning or AI models.

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

This is not applicable, as there is no training set.

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