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

Two subject devices are bundled into this 510(k) submission. The subject devices, the Nitrile Powder Free Examination Gloves and the Chemotherapy Nitrile Powder Free Examination Gloves, are single use, disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff and tested for use with chemotherapy drugs. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These gloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state. The two subject devices proposed are identical in terms of sizes, materials, color, specification, and process. The only difference between the two is the chemotherapy drug labeling.

The provided document is a 510(k) summary for Nitrile Powder Free Examination Gloves and Chemotherapy Nitrile Powder Free Examination Gloves. It details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Crucially, this document is for a Class I medical device (gloves) and explicitly states that "Clinical data is not required for marketing clearance of patient examination gloves." Therefore, there are no acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance related to an AI/ML device as none of this applies to the product described.

Instead, the document focuses on demonstrating that the gloves meet established performance standards for physical properties, barrier integrity, and biocompatibility.

Here's an analysis based on the information provided, specifically highlighting why the requested AI/ML-related information is absent and what was evaluated:

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

The document provides tables of non-clinical tests and their requirements, which serve as the acceptance criteria for these physical and chemical properties.

2. Sample sizes used for the test set and the data provenance

The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., how many gloves were tested for watertightness, or how many samples for biocompatibility). The tests are standardized (ASTM, ISO), meaning they have established sample size requirements for their methodologies, but the specific numbers are not presented in this summary.

Data provenance: The tests were performed by the manufacturer (KL-Kepong Rubber Products Sdn. Bhd. in Malaysia) or accredited labs they contracted. The data is prospective, generated specifically for this submission.

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

Not applicable. This is not an AI/ML device; therefore, there is no "ground truth" to be established by experts in the context of clinical interpretation or diagnosis. The ground truth for these device properties is based on adherence to established international (ISO) and national (ASTM) standards and laboratory testing protocols.

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

Not applicable. There is no subjective interpretation or diagnostic outcome to adjudicate for this type of device. The tests are objective and quantitative measurements against predefined specifications.

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/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for this device's performance is objective and defined by established industry and regulatory standards for physical properties (e.g., dimensional measurements, tensile strength, elongation, freedom from holes, residual powder) and chemical resistance/biocompatibility via standardized testing protocols (e.g., ASTM D6978 for chemotherapy drug permeation, ISO 10993 for biocompatibility).

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. This is not an AI/ML device.

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