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

Private lebel-Nirile Examination Gloves Powder Free, Patient Examination Gloves, Nitrile 80 LZA. The document also provides detailed specifications for the gloves including sizes (XS, S, M, L, XL), length, width, and thickness at the cuff, palm, and finger tip. It also lists physical properties before and after aging, including Tensile Strength and Ultimate Elongation.

The provided document describes the acceptance criteria and performance of "Private label-Nitrile Examination Gloves Powder Free" (Nitrile Patient Examination Gloves Pre-powdered) manufactured by PT. Berlian Glovindo.

Here's an breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the sample size used for the performance testing.
• Data Provenance: The testing appears to have been conducted by the manufacturer, PT. Berlian Glovindo, based in Ceram, Indonesia, to certify the gloves meet specific standards. The data is retrospective in the context of the 510(k) submission, meaning the testing was 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 provided in the document. For physical examination gloves, "ground truth" typically refers to objective measurements and adherence to established industry standards (like ASTM D 3578), rather than expert consensus on subjective interpretations.

4. Adjudication method for the test set:

• This information is not applicable/provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective assessment by multiple human readers (e.g., medical image interpretation). For a device like examination gloves, performance is determined by 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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, not for physical medical devices like examination gloves. The document pertains to the performance of the gloves themselves, not the performance of human users with or without AI assistance.

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

• Not applicable. This device is a physical product (examination gloves), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.

7. The type of ground truth used:

• The ground truth is based on objective measurements and adherence to established industry standards. Specifically, the document states:
  • "We certify that these gloves meet ASTM D 3578 Standard."
  • "Meets FDA pinhole requirement."
  • "Meets labeling claim."

8. The sample size for the training set:

• Not applicable. This device is a physical product, not an AI model requiring a training set.

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

• Not applicable. As mentioned above, there is no training set for this type of device.

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