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Powder free vinyl patient examination glove is a Non-Sterile 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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and study information for the "Non-Sterile Powder Free Vinyl Examination Gloves, Clear (Non-colored)" 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 explicitly state the specific sample size used for each test. However, it indicates that the tests were conducted according to the specified ASTM standards (D 5250-06, D6124-06), 21 CFR 800.20, and ISO10993-10. These standards typically prescribe minimum sample sizes for testing.

The data provenance is not explicitly mentioned as "retrospective" or "prospective" nor does it specify the country of origin where the tests were performed. However, given that SHIJIAZHUANG GLORY PLASTIC CO., LTD is located in China, it is reasonable to infer the testing was likely conducted in or commissioned by the manufacturer.

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 and therefore not provided in the document. The device is a patient examination glove, and its performance criteria are based on objective physical, chemical, and biological tests governed by established standards, not on expert interpretation of complex data.

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

This is not applicable as the tests are objective measurements against defined standards, not subjective interpretations requiring adjudication among experts.

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. The device is a medical glove, not an AI-assisted diagnostic or imaging tool that would involve human readers or AI.

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

This is not applicable. The device is a patient examination glove, and its performance is evaluated based on physical, chemical, and biological properties, not an algorithm.

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

The "ground truth" for this device is based on pre-defined specifications and objective measurements according to recognized international and national standards. This includes:

• ASTM standards: For physical properties, dimensions, and powder residual.
• 21 CFR 800.20: For freedom from pinholes (water leak test).
• ISO10993-10 equivalent tests: For biocompatibility (Primary Skin Irritation and Dermal Sensitization).

8. The sample size for the training set:

This is not applicable. The device is a patient examination glove, not a machine learning model, so there is no "training set."

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

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

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