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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 5250-06.

Here's an analysis of the provided information regarding the device's acceptance criteria and the study demonstrating its compliance:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for testing the various characteristics. However, for the biocompatibility tests:

• Primary Skin Irritation: "rabbits" (plural, but exact number not specified).
• Dermal Sensitization: "guinea pig" (singular or plural, but exact number not specified).

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable to the type of device and testing described. The "ground truth" for glove performance refers to meeting established engineering and biological standards, not expert interpretation of medical images or conditions.

4. Adjudication Method for the Test Set:

Not applicable. The testing involves objective measurements against established standards, not interpretation that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done, nor is it applicable to this type of medical device. This device is an examination glove, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a physical product (gloves), not an algorithm or AI system.

7. Type of Ground Truth Used:

The ground truth for the device's performance is based on established industry standards and regulatory requirements:

• ASTM standard D 5250-06 (for dimension, physical properties, powder amount)
• 21 CFR 800.20 (for freedom from pinholes)
• ISO 10993-10 (for biocompatibility, referred to generally in the nonclinical discussion)

8. Sample Size for the Training Set:

Not applicable. There is no mention or indication of a "training set" as this is not an AI/ML device. The testing described is for a manufactured product against specified performance standards.

9. How the Ground Truth for the Training Set was Established:

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

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