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Powder Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Vinyl Patient Examination Gloves Are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Application.

The provided document describes the acceptance criteria and performance data for Powder Free Vinyl Patient Examination Gloves (K211177). This is a medical device, and the data provided relates to its physical performance and biocompatibility, not an AI/ML-based diagnostic or imaging device. Therefore, many of the requested fields (such as sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC studies, standalone algorithm performance, and ground truth types related to AI/ML) are not applicable (N/A) for this type of medical device submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Pinhole Test: 125 gloves were sampled.
• Other Physical and Biocompatibility Tests: Sample sizes are not explicitly stated for all tests but are implied by the standards referenced (e.g., "N=5" for residual powder).
• Data Provenance: The manufacturer is Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. located in Shijiazhuang City, Hebei Province, China. The testing was conducted to meet international and US standards (ASTM, ISO, CFR). Specific country of origin for data collection for these non-clinical tests is not detailed beyond the manufacturer's location, but the tests generally follow standardized laboratory protocols rather than clinical data collection. This would be considered prospective testing against established specifications, not retrospective clinical data.

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

• N/A. This is not relevant for the type of device and testing performed. The "ground truth" for these tests is defined by the objective physical and chemical properties measured against recognized industry standards (ASTM, ISO). No expert clinical assessment of "ground truth" is involved.

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

• N/A. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical studies or expert evaluations, which is not applicable here. The tests are objective measurements based on specified standard methods.

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

• N/A. This is a physical non-diagnostic product (gloves). MRMC studies are for evaluating diagnostic tools involving human interpretation, often in conjunction with AI.

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

• N/A. This device does not have an algorithm or AI component.

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

• The "ground truth" is defined by established engineering and material science standards and specifications (e.g., ASTM D5250-19, ISO 10993-10, ISO 10993-5, ASTM D6124-06, ASTM D5151-19). These standards provide objective, measurable criteria for acceptable performance and biocompatibility.

8. The sample size for the training set

• N/A. This is a physical non-diagnostic product. There is no "training set" in the context of AI/ML.

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

• N/A. This is a physical non-diagnostic product. No AI/ML training set or associated ground truth establishment method is applicable.

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