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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

The proposed device is Powder Free Examination Gloves. The proposed device is Clear (non-colored). The proposed device is non-sterile.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what's available and noting what's not:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test, but quantities like "Checked on 5pcs sub-samples (N=5)" are mentioned for "Residual Powder." "Inspection Level I AQL2.5" is an AQL (Acceptance Quality Limit) sampling plan, implying a specific sample size based on the lot size, but the exact number of units tested is not provided.
• Data Provenance: The studies were non-clinical tests performed by Anhui Powerguard Technology Co.,Ltd, likely in China (country of origin of the manufacturer). The studies are retrospective in the sense that they were conducted specifically for this 510(k) submission, not ongoing clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This device is a medical glove undergoing non-clinical performance testing. The "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO). Therefore, "experts" in the context of clinical interpretation or diagnosis are not relevant here. The "experts" would be the scientists and engineers conducting the tests according to the standard protocols. Their qualifications are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This is not a study involving human interpretation or adjudication of results in the way described (e.g., radiologists reviewing images). Performance is measured against physical and chemical 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:

• No, an MRMC study was not done. This device is a medical glove, not an AI or diagnostic imaging device.

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

• Not applicable. This is not an algorithmic device.

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

• The "ground truth" for the device's performance is defined by the acceptance criteria of recognized international standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-5, ISO 10993-10). These standards specify the test methods and the acceptable range of performance for each characteristic (e.g., tensile strength, elongation, freedom from pinholes).

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device.

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