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Powder free 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.

powder free vinyl patient examination gloves, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.

The provided text describes the 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves (Light Yellow)." As such, the information contained does not pertain to the development or validation of a medical AI device. Instead, it details the safety and effectiveness information for a physical medical device (examination gloves) compared to a predicate device.

Therefore, many of the requested sections about AI device validation criteria, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance, are not applicable to this document.

Here's an analysis of the available information based on the provided text, focusing on the acceptance criteria and the study (or tests) proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify sample sizes for each test listed (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). The studies are non-clinical, involving material performance and animal testing.

• Provenance: Non-clinical tests, likely conducted in a laboratory setting by the manufacturer or contracted labs in China (submitter's country). These are a series of tests against established international and US standards.

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

This section is not applicable. For physical device performance and biocompatibility, ground truth is established through adherence to standardized test methods and criteria defined by regulatory bodies (e.g., ASTM, FDA, ISO). No human expert consensus for a "ground truth" in the way it's used for AI models is described or relevant here.

4. Adjudication Method for the Test Set

Not applicable. The tests are laboratory-based and follow predefined protocols for pass/fail criteria, rather than requiring adjudication by multiple human observers.

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 not an AI device, and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm. The performance described is the standalone performance of the physical glove itself based on material science and manufacturing quality tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Standardized Test Methods and Specifications: Adherence to defined parameters and limits set by ASTM (American Society for Testing and Materials), FDA regulations (e.g., 21 CFR 800.20 for freedom from pinholes), and ISO standards (e.g., ISO10993-10 for biocompatibility). These standards provide the objective criteria against which the device's performance is measured.
• Predicate Device Comparison: The device is deemed substantially equivalent to a legally marketed predicate device (K070076) that also meets these standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for a physical product like examination gloves. The "ground truth" for ensuring the product meets its specifications is established through quality control processes and adherence to manufacturing standards designed to consistently produce gloves meeting the performance criteria outlined in the standards (ASTM, FDA, ISO).

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