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Nitrile Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Examination Gloves is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color have Finger Texture, Ambidextrous, single-use, and are powderfree. The product is non-sterile.

The provided document K222813 describes the acceptance criteria and the study that proves the Ecoglove Nitrile Examination Gloves meet these criteria.

Here's the detailed breakdown:

1. A table of acceptance criteria and the reported device performance:

Note: For the "In Vitro Cytotoxicity" test, the proposed device failed the initial acceptance criteria of being "Non-cytotoxic". However, the document includes a note (Note1 in Table 1) stating: "Additional testing was performed to determine if this was a systemic toxicity concern." This implies that while the initial in vitro result was
considered "Fail" against the direct "Non-cytotoxic" criterion, further investigation might have clarified that it does not pose a systemic toxicity concern.

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

The document does not explicitly state the specific sample sizes used for each performance test (dimension, physical properties, hole detection, powder residue, and biocompatibility). However, it implies that the tests were conducted according to established ASTM standards (D6319-19, D5151-19, D6124-06) and ISO standards (10993-5:2009, 10993-10:2021, 10993-23:2021, 10993-11:2017). These standards typically specify sampling plans and test methodologies.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are non-clinical performance and biocompatibility tests, which are typically conducted in a controlled laboratory setting.

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

This information is not applicable. The device is a "Nitrile Examination Glove," which is a physical product subject to objective performance testing against established standards, not a diagnostic or AI-driven device requiring expert interpretation for ground truth.

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

This information is not applicable. Adjudication methods are typically employed in studies involving human interpretation or subjective assessments, like medical imaging or clinical trials. The tests performed for this device are objective laboratory tests.

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. This device is a medical glove, not an AI-assisted diagnostic tool.

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

This information is not applicable. This is not an algorithm-based device.

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

The "ground truth" for the performance tests relies on industry standards (ASTM and ISO) which define acceptable limits for physical properties, barrier integrity, and chemical residue. For biocompatibility, the ground truth is defined by the criteria established in the ISO 10993 series of standards.

8. The sample size for the training set:

This information is not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

This information is not applicable due to the reasons stated in point 8.

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