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Powder Free Nitrile Examination Gloves, Blue, Non-Sterile is a disposable device and made of Synthetic Rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test.

Here's an analysis of the acceptance criteria and study information for the device, based on the provided text:

Device: Powder Free Nitrile Examination Gloves, Blue, Non-Sterile

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states that the device "meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test" (Section 5.0 and 10.0), which are foundational for examination gloves.

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

• Sample Size: Not explicitly stated in the provided text. The document refers to "performance test data of the non-clinical tests" but does not give specific sample sizes for each characteristic.
• Data Provenance: The device manufacturer (PT. WRP Buana Multicorpora) is based in Indonesia. The testing standards mentioned (ASTM, FDA) are international/US standards, implying the testing was conducted to these requirements. The text does not specify the country of origin of the data collection beyond the manufacturer's location. The studies are described as "non-clinical tests." It is a prospective study as the data supports a premarket notification for a new device.

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

• Not applicable as this is a non-clinical device (examination glove) and the testing involves physical and chemical property assessments rather than expert interpretation of medical images or patient conditions. The "ground truth" is established by adherence to defined ASTM and FDA engineering/testing standards.

4. Adjudication method for the test set:

• Not applicable for this type of non-clinical device testing. The results are based on objective measurements against established 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-assisted diagnostic device.

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

• Not applicable. This is not a software algorithm or AI device. The "standalone" performance refers to the intrinsic properties of the physical glove itself, tested against established standards.

7. The type of ground truth used:

• For Dimensions, Physical Properties, Freedom from Pinholes, and Powder Free Residue: The ground truth is defined by established engineering and material testing standards (ASTM D 6319-00ae3, FDA 21 CFR 800.20, FDA 1000 ml Water Leak Test, ASTM D 6124-01). The device passes or fails based on objective measurements against these predefined thresholds.
• For Biocompatibility (Primary Skin Irritation and Dermal Sensitization): The ground truth is established through pre-clinical animal testing (specifically in Rabbits for skin irritation). The "Passes" outcome indicates no adverse biological reaction following standard protocols.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device.

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