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

Class 1 Nitrile Patient Examination Glove 80LZA, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.

The provided text describes the acceptance criteria and performance data for "Powdered Nitrile Examination Gloves" by SPI GLOVES SDN. BHD. This is a medical device and the information is presented as part of a 510(k) summary submitted to the FDA.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the 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: The document does not explicitly state the specific sample sizes used for each test. However, it indicates an AQL=2.5% for the watertight test, which implies a sampling plan based on statistical quality control standards like ISO 2859-1 (which ASTM D3578 references). For other tests (length, width, thickness, physical properties), a specific sample size is not provided.
• Data Provenance: The testing was performed by SPI GLOVES SDN. BHD., a company located in Ipoh, Perak, Malaysia. The data is likely prospective as it represents the performance data for the specific device manufactured by the submitter.

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 section is not applicable. The device is a physical product (examination gloves), and its performance is evaluated against established technical standards (ASTM D6319-00a53, FDA requirements) and laboratory tests, not through expert interpretation or clinical ground truth in the way medical imaging or diagnostic algorithms are. The "ground truth" is defined by these objective standards.

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

This section is not applicable. As explained above, the evaluation relies on objective measurements and compliance with technical standards and lab tests, not subjective interpretation requiring adjudication.

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 section is not applicable. This describes a physical product, not an AI-powered diagnostic or assistive tool for human readers.

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

This section is not applicable. This describes a physical product, not an algorithm.

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

The "ground truth" for this device's performance is established by objective technical standards and laboratory testing. Specifically:

• ASTM D6319-00a53 Standard
• FDA 1000 ml watertight test
• FDA minimum powder residual content
• Biocompatibility Tests (Primary Dermal Irritation Test and Guinea Pig Sensitization)

8. The sample size for the training set

This section is not applicable. This device is a manufactured product, not a machine learning model, so there is no concept of a "training set."

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

This section is not applicable for the same reason as point 8.

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