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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 examiner.

Nitrile Powder Free Blue Examination Gloves, Non-Sterile are Class I patient examination gloves bearing the product code Nitrile – LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. These gloves are blue in color and are powder free. The gloves are ambidextrous single use disposable devices that come in four sizes (S, M, L and XL).

The provided text describes the acceptance criteria and the results of a study for the "Nitrile Powder Free Blue Examination Gloves, Non-Sterile". Here's the information broken down as requested:

1. A table of acceptance criteria and the 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 specific sample sizes for each test. Instead, it refers to standards like ASTM and ISO, which would define the required sample sizes for such tests. For instance, for "Freedom of Holes," it refers to "AQL 1.5 with G1," which implies a sampling plan defined by ASTM D5151-19.

The data provenance is from Mah Sing Healthcare Sdn Bhd, located in Kuala Lumpur, Malaysia. The tests are non-clinical bench tests and biocompatibility tests conducted to support a premarket notification (510(k)). These are typically prospective tests performed specifically for the submission.

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 information is not applicable. The device is a medical glove, and the tests relate to its physical properties, chemical properties (residual powder), and biocompatibility, as measured by standard laboratory methods. There is no mention of human expert assessment or ground truth establishment in the context of medical image analysis or similar diagnostic tasks.

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

This information is not applicable. Adjudication methods are typically relevant in clinical studies or studies involving human interpretation of data where disagreements need to be resolved. The tests performed are laboratory-based and follow standardized testing protocols.

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 information is not applicable. MRMC studies and AI assistance effectiveness are relevant for AI/ML-enabled diagnostic devices. The device in question is a medical glove, not an AI diagnostic tool.

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

This information is not applicable. The device is a medical glove and does not involve any algorithms or AI.

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

The "ground truth" for the tests performed is based on:

• Standardized measurement techniques and physical limits defined by international standards (ASTM D6124-06, ASTM D5151-19, ASTM D6319-19).
• Biological and chemical assays for biocompatibility (ISO 10993-10, ISO 10993-5, ISO 10993-11) where the "truth" is whether the material elicits a specific biological response (e.g., irritation, sensitization, cytotoxicity, systemic toxicity) above a defined threshold.

8. The sample size for the training set

This information is not applicable. There is no training set as the device is a physical product (medical glove) and not an AI/ML system.

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

This information is not applicable, as there is no training set.

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