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This powder free vinyl patient examination glove 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.

powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4.

Requested information about the acceptance criteria and study that proves the device meets the acceptance criteria:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. This document pertains to patient examination gloves, which undergo non-clinical testing rather than classification with a "test set" in the context of AI/ML or medical imaging devices. The tests are performed on samples of the manufactured gloves. The document does not specify exact sample sizes for each test but refers to standard testing methods. The data provenance is derived from direct testing of the manufactured gloves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For medical device manufacturing like gloves, "ground truth" is established by adherence to specified physical, chemical, and biological standards (e.g., ASTM, CFR). No human experts are used to subjectively determine a "ground truth" for the test set in the way they would for diagnostic imaging.

4. Adjudication method for the test set: Not applicable. Since the evaluation relies on objective measurements against predefined standards, no subjective adjudication method (like 2+1 or 3+1 consensus) is required.

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 device is a patient examination glove, not an AI or diagnostic imaging device. Therefore, MRMC studies and AI assistance are irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used: The ground truth is defined by objective, quantitative, and qualitative criteria established in international and national standards (ASTM standard D 5250-00e4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10). These standards specify acceptable ranges for dimensions, physical properties, limits for pinholes, maximum powder residual, and biological response criteria for biocompatibility tests.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of manufacturing and testing patient examination gloves.

9. How the ground truth for the training set was established: Not applicable. There is no "training set" for this type of device. The established standards are the "ground truth" against which all manufactured gloves are evaluated.

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