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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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted to your requests:

Acceptance Criteria and Device Performance Study

The device reviewed is "Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)" from Hebei Handform Plastic Products Co.,Ltd.

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 numerical sample size for the tests conducted to demonstrate compliance with ASTM standards, 21 CFR 800.20, and ISO10993-10.
The provenance of the data is implied to be from the manufacturer's testing (Hebei Handform Plastic Products Co.,Ltd. in China). The study is retrospective in the sense that the results are being reported after the tests were conducted, but it's not a retrospective analysis of existing clinical data. It is a report of non-clinical testing performed to establish safety and effectiveness.

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

Not applicable. The tests conducted (dimensional checks, physical properties, pinhole freedom, powder residual, and biocompatibility) are objective, laboratory-based tests that do not rely on expert interpretation for "ground truth" in the same way, for example, a medical imaging study would. The ground truth is defined by the objective measurements against established standards.

4. Adjudication method for the test set

Not applicable. As described above, the tests are objective measurements against predefined standards. There is no subjective interpretation that would require an adjudication method like 2+1 or 3+1.

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-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.

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

Not applicable. This device is a physical product (a glove), not an algorithm or software.

7. The type of ground truth used

The ground truth used for the acceptance criteria is based on established industry and regulatory standards:

• ASTM standard D 5250-06 (for Dimension, Physical Properties, Powder Residual)
• 21 CFR 800.20 (for Freedom from pinholes)
• ASTM standard D6124-06 (for Powder Residual)
• ISO10993-10 (for Biocompatibility, specifically Primary Skin Irritation and Dermal Sensitization)

8. The sample size for the training set

Not applicable. This 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

Not applicable, as there is no training set for this type of device.

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