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The Examination gloves-Type A (Latex gloves) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The proposed device, The Examination gloves-Type A ( Latex gloves ) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is provided non-sterile and the shelf life is 5 years.

This document is a 510(k) summary for Examination gloves-Type A (Latex gloves). It details the device's characteristics, intended use, and a comparison to a predicate device, along with non-clinical performance test data to demonstrate substantial equivalence.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

2. 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 Watertight test: 200 pieces (gloves).
• Sample Size for other tests: The document specifies "Minimal for all sizes" or "for all sizes" without providing explicit sample counts for each specific physical and chemical test.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. All submissions are from China.

3. 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)

This device is a physical medical device (examination gloves), not an AI/software device that requires expert adjudication for ground truth related to image interpretation or diagnosis. The "ground truth" for these tests is established by standardized methods and measurements as defined by ASTM and ISO standards, not by expert consensus. Therefore, this question is not applicable in the context of these non-clinical performance tests.

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

Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI/imaging studies where there might be inter-reader variability. For the physical and chemical tests conducted on examination gloves, the determination of pass/fail is based on objective measurements against predefined acceptance criteria from international standards. There is no mention of an adjudication method as it is not relevant to this type of testing.

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

This question is not applicable. The device in question is examination gloves, not an AI-assisted diagnostic tool. Therefore, MRMC studies or assessments of human reader improvement with AI assistance are irrelevant.

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

This question is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system.

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

The "ground truth" for the performance tests on these examination gloves is based on:

• Standardized measurement and testing protocols: Adherence to established international standards (ASTM and ISO).
• Objective physical and chemical properties: Measurements of dimensions, tensile strength, elongation, residual powder, protein content, and biological reactivity (skin sensitization, irritation, systemic toxicity).
• Defined Pass/Fail criteria: Each test has specific numerical or qualitative acceptance criteria derived from the respective standard.

8. The sample size for the training set

This question is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."

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

This question is not applicable for the same reason as in point 8.

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