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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06

The document provided describes the acceptance criteria and study for the Rich Mountain Medical Products Inc. Disposable Vinyl Synthetic Examination Gloves, Powdered Yellow Color.

1. Table of acceptance criteria and reported device performance:

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact number of samples is not explicitly stated, but these AQL (Acceptable Quality Limit) parameters refer to sampling plans as defined in statistical quality control standards.
• Watertightness Test (based on ASTM D-5151-06): Samplings of AQL 2.5, Inspection level I. The exact number of samples is not explicitly stated, but these AQL parameters refer to sampling plans.
• Primary Skin irritation and Skin Sensitization: The document does not specify the sample size for this testing.
• Data Provenance: The document does not specify the country of origin of the data for the testing conducted. It is implied that the testing was performed in the context of Rich Mountain Medical Products Inc., which is based in China. The data would be considered retrospective in the context of this 510(k) submission, as the tests were performed prior to the submission.

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

This information is not applicable as the evaluation of medical devices like gloves primarily relies on adherence to established physical, chemical, and biological performance standards (e.g., ASTM standards, FDA watertightness tests). It does not involve human expert interpretation for establishing a "ground truth" in the same way clinical imaging or diagnostic devices would.

4. Adjudication method for the test set:

This is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., clinical trials, AI performance evaluation) to resolve discrepancies among experts. The testing here is objective measurement against 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:

This is not applicable. This submission is for a disposable medical glove, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study involving human readers or AI assistance was performed.

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

This is not applicable. The device is a physical product (gloves), not an algorithm or AI system.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by objective measurements and adherence to recognized industry standards and regulatory requirements. Specifically:

• ASTM Standard D5250-06 for physical and dimension properties.
• FDA 1000 ml Watertight Test based on ASTM D-5151-06 for barrier integrity.
• Biocompatibility testing against established criteria for primary skin irritation and sensitization.
• Conformity to 21 CFR references and "pinhole FDA requirements."

8. The sample size for the training set:

This is not applicable. This device is a physical product, not a machine learning model, so there is no "training set" in the context of artificial intelligence.

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

This is not applicable for the reasons stated in item 8.

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