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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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-004

Here's a breakdown of the acceptance criteria and study information for the "Powdered Vinyl Patient 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:

• Sample Size for Test Set: Not explicitly stated. The document refers to meeting standards without detailing the number of units tested for each characteristic.
• Data Provenance: Not explicitly stated. The studies are described as "nonclinical" and likely conducted in a laboratory setting, but the country of origin of the data is not specified. It's implicitly from the manufacturer, JIANGSU CUREGUARD GLOVE CO., LTD.

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

• Not applicable. The ground truth for this device is based on objective measurements against established industry standards (ASTM, CFR, ISO) rather than expert consensus on subjective interpretations.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where there might be disagreement among experts. Here, the tests involve objective measurements against predefined limits.

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 physical medical glove, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used:

• The ground truth used is based on objective measurements conforming to recognized standards (e.g., ASTM standard D 5250-00d for dimensions, physical properties, and powder amount; 21 CFR 800.20 for freedom from pinholes; ISO10993-10 for biocompatibility).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The assessment is based on physical and biological testing against established specifications.

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

• Not applicable, as there is no training set involved for this type of device. The "ground truth" for ensuring compliance is established by the referenced standards themselves and the methods described within those standards for testing.

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