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Powder free vinyl patient examination glove is 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.

This is a Powder Free Vinyl Patient Examination Glove, Clear (non-colored).

1. Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not specify exact sample sizes for each test in the test set. It refers to compliance with standards like ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, and ISO10993-10, which would inherently include testing procedures and sample size requirements within those standards.

The data provenance is not explicitly stated as retrospective or prospective, nor the country of origin. However, the manufacturer is HEBEI FAVOR PLASTIC CO., LTD from China.

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

Not applicable. This device is a physical product (gloves) and its performance is evaluated against established physical and chemical standards, not through interpretation by medical experts.

4. Adjudication method for the test set:

Not applicable. The evaluation is based on objective measurements against engineering and medical standards, not on subjective interpretations requiring adjudication.

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 and does not involve AI or human "readers."

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

Not applicable. This device is a patient examination glove and does not involve an algorithm.

7. The type of ground truth used:

The ground truth is established by adherence to recognized national and international standards for medical devices, specifically:

• ASTM D5250-06 (Standard Specification for Vinyl Patient Examination Gloves)
• ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
• 21 CFR 800.20 (Pinhole, Tensile Strength, and Elongation Requirements for Surgeon's Gloves and Patient Examination Gloves)
• ISO10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)

8. The sample size for the training set:

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a physical product, not an AI/ML algorithm.

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