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The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The propose devices is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are four sizes, includes small (7"), medium (8"), large (8.5"), X-large (9") for optional. The gloves are provided with blue color. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge.

This is a 510(k) premarket notification for nitrile examination gloves, not an AI/ML medical device. Therefore, the request for acceptance criteria and study details related to AI/ML performance metrics (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone performance) is not applicable.

The document assesses the substantial equivalence of the proposed device (Nitrile Examination Gloves) to a predicate device (Powder Free Nitrile Patient Examination Gloves, Blue Color) based on non-clinical testing and comparison of technological characteristics.

Here’s a breakdown of the relevant information provided:

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

The document provides a comparison of the proposed device with a predicate device, referencing ASTM standards for acceptance criteria. The performance of the proposed device is stated as meeting these requirements.

Note: The table above extracts information primarily from the "Comparison of technological characteristics with the predicate devices" section and the "Non-Clinical Testing" section.

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

This information is not applicable as this is a medical glove submission and not an AI/ML device. The "test set" in this context refers to the samples of gloves tested according to the specified ASTM and ISO standards, not a data set for an algorithm. The document doesn't detail the sample sizes for each physical or biocompatibility test, but it indicates adherence to the standards. The manufacturing country of origin is China (Guang Dong Kingfa SCI. & TECH.CO., LTD.).

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 is not applicable. "Ground truth" in the AI/ML sense is not relevant here. The "ground truth" for glove performance is established by the defined ASTM and ISO standards, and testing is performed by laboratories that adhere to these standards.

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

This is not applicable. Adjudication methods are typically associated with resolving discrepancies in expert interpretations of medical images or data. Standardized laboratory testing methods do not involve such adjudication processes.

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 is not applicable. This is not an AI-assisted device.

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

This is not applicable. This is not an algorithmic device.

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

The "ground truth" for the performance of the gloves is based on established industry standards (ASTM D6319-19, ASTM D3767-03(2020), ASTM D5151-19, ASTM D6124-06(2017), ASTM D573-04(2019), ASTM D412-16, ISO 10993-10: 2010, ISO 10993-11:2017). These standards define the acceptable physical properties and biocompatibility characteristics for medical examination gloves.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device.

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

This is not applicable as this is not an AI/ML device.

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