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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or lingers to prevent contamination between patient and examiner.

White Vinyl Exam Gloves Powder Free is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove. 80LYZ. and meets all requirement of ASTM Standard D5250-06.

The provided document is a 510(k) summary for the "White Vinyl Exam Gloves Powder Free." This is a medical device application for approval based on substantial equivalence to an already marketed predicate device, not a clinical study report for an artificial intelligence or diagnostic device. Therefore, many of the requested elements are not applicable to this type of submission.

However, I can extract the acceptance criteria and performance data as presented for the non-clinical tests conducted to demonstrate substantial equivalence of the proposed device to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (medical gloves), the "acceptance criteria" are typically defined by recognized standards (like ASTM D5250-06) and the performance of the predicate device. The "device performance" refers to the results obtained from testing the proposed device against these standards and in comparison to the predicate.

The study that proves the device meets the acceptance criteria:

The study is described as "Non-Clinical tests performed for Determination of Substantial Equivalence." These tests were conducted based on ASTM standards (D5250-06, D6124-06, D5151-06) and FDA's 1000 ml. Water Fill Test. Biocompatibility testing (Primary Skin Irritation and Skin Sensitization) was also performed. The conclusion states that the proposed device conforms fully to ASTM-D-5250-06 standard, applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements, and labeling claims.

Regarding the other requested information, most are not applicable to this type of device submission:

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

• Test Set Sample Size: For physical tests (Tensile Strength, Elongation, Dimensions, Thickness), specific sample sizes are not explicitly stated beyond "samplings of AQL 2.5" for the Water Fill Test and "125 pieces gloves" for pinhole testing. The number of gloves tested for other physical properties is not detailed.
• Data Provenance: The tests were conducted by the manufacturer, Shandong Dawei Medical Products Co., Ltd., presumably in China, to demonstrate compliance with US FDA regulations. The data is retrospective, as it's generated for a submission of a completed device.

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

• Not applicable. This is not an AI/diagnostic device where expert ground truth is typically established. The "ground truth" here is defined by objective physical and chemical testing against established engineering standards and regulatory requirements.

4. Adjudication method for the test set:

• Not applicable. Not an AI/diagnostic device. Performance is determined by objective measurements against quantitative 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 glove, not an AI or diagnostic device designed to be used by human readers for interpretation.

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

• Not applicable. This is a physical medical device (glove), not an algorithm.

7. The type of ground truth used:

• For Physical/Performance Properties: The "ground truth" is defined by the objective measurements obtained from testing the gloves, compared against the specified limits in ASTM standards (D5250-06, D6124-06, D5151-06) and the performance characteristics of the legally marketed predicate device (K992821).
• For Biocompatibility: The "ground truth" for primary skin irritation and dermal sensitization is determined by the results of specific biological tests, indicating whether the device elicited an irritant or sensitizing response.

8. The sample size for the training set:

• Not applicable. This is not an AI device, so there is no "training set." The product is manufactured according to specifications derived from standards.

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

• Not applicable. There is no training set as it is not an AI device.

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