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Powdered 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.

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

The provided text describes the regulatory submission for Powdered Vinyl Patient Examination Gloves. It details the device's characteristics and its equivalence to a predicate device, primarily through adherence to established standards.

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

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 a distinct "test set" sample size in the context of typical AI/software performance studies. The testing described pertains to physical and biological properties of the gloves, and the sample sizes for these tests are not explicitly stated. The data provenance is internal testing by the manufacturer, SHIJIAZHUANG WINFUL PLASTIC CO.,LTD, located in China. The studies are by nature retrospective as they are conducted on manufactured products to ensure compliance.

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

This information is not applicable as the device is a physical medical device (examination gloves), not an AI/software device requiring expert interpretation of data to establish ground truth for a test set. The "ground truth" for the device's performance is objective measurements against established ASTM and CFR standards, as performed by laboratory testing.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. No adjudication method is described for determining the "ground truth" of the physical and biological characteristics of the gloves.

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 an examination glove, not an AI/software device that would involve human readers or AI assistance.

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

This information is not applicable. The device is an examination glove, and there is no algorithm or human-in-the-loop involved in its function or evaluation.

7. The type of ground truth used

The ground truth used for evaluating the device is based on objective measurement against established regulatory and industry standards. Specifically:

• ASTM standard D 5250-00e4 for dimensions, physical properties, and powder amount.
• 21 CFR 800.20 for freedom from pinholes (waterleak test).
• ISO 10993-10 for biocompatibility (Primary Skin Irritation and Dermal sensitization tests).

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of this device, as it is a physical product and not an AI/machine learning model.

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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