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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 Examination Gloves (with color Beige or Clear) is a patient examination glove made from poly (vinvl chloride), non-sterile (as per 21 CFR 880.6250, Class I). 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 document provides information about the non-clinical performance evaluation of "Disposable Powder Free Vinyl Examination Gloves, Beige/Clear" to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

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 sizes used for each specific test. For instance, for "Freedom from holes," it mentions "G-I/AQL 2.5," which implies a sampling plan, but the exact number of units tested is not provided. The data provenance is not specified beyond being "nonclinical bench testing" conducted by the manufacturer. It does not mention countries of origin for the data or whether it was retrospective or prospective, as these are typically not applicable to bench testing of this nature.

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 section is not applicable as the study involves non-clinical bench testing of physical and chemical properties of gloves, not medical image analysis or diagnostic performance requiring expert interpretation. The "ground truth" is established by adherence to recognized international standards (ASTM, ISO) for material properties.

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

This is not applicable as the tests are objective, quantitative measurements against predefined criteria as per ASTM and ISO standards, not subjective assessments requiring adjudication by multiple readers.

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 is not applicable as the device is a medical glove, a physical product, and does not involve AI assistance or human reader interpretation.

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 glove, not an algorithm or AI system.

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

The ground truth for this device is based on established international standards and specifications for medical gloves, specifically:

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

These standards define the acceptable physical properties and biocompatibility.

8. The sample size for the training set

This is not applicable as this study is a non-clinical performance evaluation of a medical device (glove) against established standards, not a machine learning or AI algorithm that requires a training set.

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

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

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