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A non-powdered 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.

A Disposable Powder Free Vinyl Exam Glove (with color Black, Blue, or Purple) is a patient examination glove made from poly (vinyl chloride), non-sterile (as per 21 CFR 880.6250, Class I). This device is available in size S, M, L, and XL. The operation principle of this medical device is to provide single use barrier protection for the wearer and the device meets all the requirement specifications for barrier protection, tensile properties as defined in ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

The provided text describes the acceptance criteria and the results of non-clinical performance testing for a medical device, specifically Disposable Powder Free Vinyl Exam Gloves.

Here's a breakdown of the requested information:

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)

The document does not explicitly state the sample size used for each specific test or the data provenance. It only states "Pass" for each criterion, indicating that the tests were conducted.

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 information is not applicable as the acceptance criteria are based on standardized test methods and physical/chemical properties, not on expert interpretation of medical images or patient data.

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

This information is not applicable as the assessment involves standardized laboratory tests with objective measurements, not expert adjudication of subjective findings.

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 information is not applicable. The device is a physical product (examination gloves), not an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant.

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

This information is not applicable. The device is a physical product, not a standalone algorithm.

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

The "ground truth" for the performance evaluation of these gloves is based on established international and national standards for physical, chemical, and biological properties of medical gloves. Specifically, the tests reference:

• ASTM D3767 (for Dimension)
• 21 CFR 800.20 & ASTM D5151-19 (for Freedom from holes)
• ASTM D412-16 & ASTM D573-04 (for Tensile strength & Elongation)
• ASTM D6124-06 (for Powder Residual)
• ISO 10993-10:2010 and ISO 10993-23:2021 (for Biocompatibility - Skin Irritation and Sensitization)
• ISO 10993-5:2009 (for Biocompatibility - Cytotoxicity)

These standards define the acceptable range or condition for each characteristic.

8. The sample size for the training set

This information is not applicable. The described study is a non-clinical performance evaluation against predetermined standards, not a machine learning model requiring a training set.

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

This information is not applicable for the same reasons as point 8.

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