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The Powder Free Neoprene Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The Powder Free Neoprene Examination Gloves, Non Sterile meets all the The Towder 1160 - Neopandard D 3578 - 00 and FDA 21 CFR 800.20.

The provided document describes the WRP Asia Pacific Sdn Bhd "Powder Free Neoprene Examination Gloves, Non-Sterile". Here's an analysis of the acceptance criteria and the study data as requested:

Acceptance Criteria and Device Performance for Powder Free Neoprene Examination Gloves, Non-Sterile

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific test (Dimensions, Physical Properties, Pinhole, Powder-Free, Biocompatibility). The testing was conducted by WRP Asia Pacific Sdn Bhd in Malaysia. It is implied to be prospective testing carried out for the purpose of the 510(k) submission, as these are performance tests of the new 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 a medical device (examination gloves) where performance is determined by objective physical and chemical testing against established standards, not through expert interpretation of images or clinical outcomes.

4. Adjudication method for the test set

Not applicable. Performance is determined by objective measurements against established ASTM and FDA 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 not an AI-powered diagnostic device, but a physical medical device (gloves).

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

Not applicable. This is not an AI-powered diagnostic device.

7. The type of ground truth used

The "ground truth" for the performance determination of these examination gloves were established industry standards and regulatory requirements:

• ASTM D 3578 - 00: Standard Specification for Rubber Examination Gloves. This standard dictates requirements for dimensions, physical properties, and freedom from pinholes.
• FDA 21 CFR 800.20: This regulation pertains to waterleak test on pinhole AQL (Acceptance Quality Limit).
• ASTM D 6124 - 00: Standard Test Method for Residual Powder on Medical Gloves.
• Biocompatibility Standards: Primary Skin Irritation in Rabbits and Dermal Sensitization tests (methods typically follow ISO 10993 series or equivalent guidelines).

8. The sample size for the training set

Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for the manufacturing and testing of examination gloves.

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

Not applicable for the reasons stated in point 8.

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