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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The qloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in five sizes: extra-small, small, medium, large, and extra-large.

The provided text describes the acceptance criteria and performance of a medical device, specifically "Disposable Nitrile Medical Examination Gloves (Tested for Use with Chemotherapy Drugs)" (K212834). However, it is not an AI/ML medical device, but rather a physical product.

Therefore, many of the requested criteria for an AI/ML study (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, training set details, etc.) are not applicable to this document. The document details bench testing and biocompatibility assessments, which are standard for physical medical gloves.

Below is a table summarizing the acceptance criteria and reported device performance based on the provided document, along with a clarification of why other requested information is not present for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

Clarification regarding AI/ML specific questions:

The provided document is a 510(k) summary for a physical medical device (examination gloves), not an Artificial Intelligence/Machine Learning (AI/ML) based medical device. Therefore, the following requested information is not applicable to this submission:

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for physical product testing. Performance testing is done via bench methods on manufactured samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties (e.g., tensile strength, hole detection) is established through standardized laboratory test methods, not expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Testing involves measurable physical properties.
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 a physical device, not an AI assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on standardized test methods and measurements (bench testing) per ASTM and ISO standards, not medical imagery or pathology.
8. The sample size for the training set: Not applicable. The device does not involve machine learning and therefore has no "training set."
9. How the ground truth for the training set was established: Not applicable.

In summary, the document details the safety and performance evaluation of a medical glove against established national and international standards for physical properties and biocompatibility. It successfully demonstrated substantial equivalence to a predicate device through these non-clinical tests.

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The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

This document describes the premarket notification for the "Disposable Nitrile Medical Examination Glove". The acceptance criteria and the study proving the device meets these criteria are detailed through a series of tables and text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• ASTM D5151 (Watertightness): For sizes XS, S, and M, 125 gloves were tested for each size (e.g., XS: 0/125 leaks, S: 1/125 leaks, M: 0/125 leaks). The sample sizes for L and XL are not explicitly stated, but the test methodology implies a standardized approach across sizes.
• Other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility): Specific sample sizes for these tests are not explicitly provided in the document.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective, beyond stating that non-clinical tests were conducted to verify the device met all design specifications.

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

Not applicable. The tests conducted are non-clinical, laboratory-based tests evaluating the physical and biological properties of the medical examination glove against recognized international and national standards (e.g., ASTM, ISO). Ground truth, in the context of expert consensus, is not relevant for these types of tests.

4. Adjudication method for the test set

Not applicable. The tests are standardized laboratory procedures with objective measurements against predefined acceptance criteria. There is no mention of expert adjudication for interpreting results.

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 a submission for a medical examination glove, which is a physical device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance evaluation of the Disposable Nitrile Medical Examination Glove is based on widely accepted, published national and international standards for medical gloves. Specifically:

• Physical properties (dimensions, tensile strength, elongation): ASTM D6319 and ASTM D412.
• Freedom from holes: ASTM D5151.
• Powder content: ASTM D6124.
• Biocompatibility (Irritation, Sensitization, Cytotoxicity): ISO 10993-10 and ISO 10993-5.

These standards define the objective and measurable criteria that the device must meet.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set".

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

Not applicable (as it's not an AI/ML device, there is no training set).

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