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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. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 (2019), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrile Powder Free Black Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs meets all the requirements of ASTM standards D6319-19, D6978-05 (2019) and FDA 21 CFR 880.6250. 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 black in color and are powder free. The gloves are ambidextrous i.e., can be worn on right hand or left hand, single use disposable devices that come in five sizes (XS, S, M, L and XL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.

The provided document is a 510(k) premarket notification for Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs, and does not pertain to an AI/ML-enabled medical device. Therefore, the information requested about acceptance criteria and studies proving the device meets them in the context of an AI/ML device (e.g., sample size for test sets, data provenance, a number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not applicable to this document.

Instead, the document describes the acceptance criteria and performance of these medical gloves based on non-clinical bench testing to demonstrate substantial equivalence to a predicate device.

Here's the relevant information from the document regarding the glove's performance:

1. A table of acceptance criteria and the reported device performance (for the non-AI device: medical gloves):

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

• Sample Size for Testing: The document does not specify the exact sample sizes for each non-clinical test (e.g., how many gloves were tested for holes, tensile strength, or chemotherapy permeation for each batch/size). The results are presented as averages or ranges across sizes.
• Data Provenance: The tests were non-clinical bench tests performed by Mah Sing Healthcare Sdn. Bhd. (Malaysia), as indicated by the sender and manufacturer information. There is no mention of country of origin of data in the sense of patient data, as this device does not use patient data for its function. All tests are by standard methods (ASTM, ISO). The studies are inherently "prospective" in the sense that they are conducted specifically for this submission against defined standards.

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):

• Not applicable. Ground truth for these physical and chemical tests is established by the specified ASTM and ISO standard test methods, which are objective, reproducible procedures. No human experts are involved in establishing "ground truth" for the physical properties of a glove in the way they would for medical image interpretation.

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

• Not applicable. As these are objective bench tests, there is no need for human adjudication of results. The results are quantitative measurements or direct observations according to specified 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:

• 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. The "standalone" performance here refers to the glove's physical and chemical properties and its resistance to chemotherapy drugs, which are measured directly.

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

• For this device, the "ground truth" is defined by the measurement outcomes according to internationally recognized standard test methods (ASTM and ISO) for physical properties (e.g., dimensions, tensile strength, freedom from holes, powder residue) and chemical resistance (chemotherapy drug permeation). For biocompatibility, it's defined by the in vivo animal study results according to ISO standards.

8. The sample size for the training set:

• Not applicable. There is no training set for a non-AI/ML device.

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

• Not applicable. There is no training set for a non-AI/ML device.

In summary, this document demonstrates the safety and effectiveness of medical gloves through adherence to established material and performance standards, not through AI/ML model validation studies.

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