Search Results

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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0084.

This document is a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, White (Non-colored)". It is for a medical device (gloves), not an AI/ML-driven diagnostic or prognostic device. Therefore, many of the requested categories in the prompt regarding AI/ML studies are not applicable.

Here's the information that can be extracted from the provided text, adapted to the nature of the device:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for testing each characteristic. The "data provenance" is not detailed, but the manufacturer is based in China. The testing would be prospective for the product being manufactured.

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

Not applicable. This is a physical product, and "ground truth" as typically applied in AI/ML contexts (e.g., expert consensus on image interpretation) is not relevant here. Performance is determined by standardized physical and chemical tests.

4. Adjudication method for the test set

Not applicable. Physical and chemical tests typically have objective pass/fail criteria derived from the standards.

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 is a medical device (gloves), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (gloves), not an algorithm.

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

The "ground truth" for the performance of the gloves is established by compliance with recognized industry standards and regulations:

• ASTM standard D 5250-00e4 (for dimensions, physical properties, and powder amount)
• 21 CFR 800.20 (for freedom from pinholes/water-leak test)
• ISO 10993-10 (for biocompatibility, specifically irritation and sensitization tests)

8. The sample size for the training set

Not applicable. This is a medical device (gloves) and does not involve AI/ML models requiring a "training set".

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

Not applicable. See point 8.

Ask a specific question about this device