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The Powder Free Pink Nitrile Examination Glove, Non-Sterile 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 Powder Free Pink Nitrile Examination Gloves, Non Sterile is equivalent to the existing model, i.e. Powder Free Blue Nitrile Examination Gloves, Non Sterile which had submitted and cleared under 510(k) number K022904. The difference in this submission is: Change of colour additive used, i.e. Pink. The modification of colour does not affect the intended use of the device as well as it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections. The Powder Free Pink Nitrile Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 6319 - 00a23 and FDA 21 CFR 800,20.

This document describes the premarket notification (510(k)) for WRP Asia Pacific Sdn Bhd's Powder Free Pink Nitrile Examination Gloves, Non-Sterile. This is a medical device submission, and the provided text does not contain a study in the context of an AI/ML device or a comparative effectiveness study with human readers. Instead, it details how the modified device (pink gloves) meets established standards for examination gloves.

Therefore, many of the requested elements for an AI/ML device study are not applicable to this submission.

Here's an analysis based on the provided text, addressing the applicable points:

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)

The document does not specify the sample sizes used for testing each characteristic. It refers to compliance with established ASTM standards and FDA regulations, which inherently define the testing methodologies, including sample sizes, for examination gloves. The data provenance is not explicitly stated as "country of origin" from a clinical study perspective, but the submitter is WRP Asia Pacific Sdn Bhd, based in Malaysia. The testing would have been performed by the manufacturer or a certified lab to demonstrate compliance with the referenced standards.

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 is not applicable. The "ground truth" for this medical device (examination gloves) is established by adherence to predefined performance standards (ASTM and FDA regulations), not by expert consensus on clinical data interpretation. The testing involves physical and chemical property measurements.

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

This is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts. For this device, compliance is determined by laboratory testing against established specifications.

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 examination gloves, not an AI/ML medical device.

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

This is not applicable. This submission is for examination gloves, not an AI/ML medical device.

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

The "ground truth" here is defined by:

• ASTM Standards: Specifically, ASTM D 6319-00aE3 for dimensions, physical properties, and freedom from pinholes. ASTM D 6124-01 for powder residual.
• FDA Regulations: Specifically, 21 CFR 800.20 for waterleak test on pinhole AQL.

These standards and regulations establish objective, measurable criteria for the performance and safety of medical examination gloves.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an AI/ML algorithm for this device. The manufacturing process of the gloves is designed to meet the specified standards.

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

This is not applicable. There is no "training set ground truth" for this device. The manufacturing specifications and quality control processes are designed to produce gloves that inherently meet the performance "ground truth" defined by the ASTM standards and FDA regulations.

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