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This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between the patient and examiner. Powder-free examination gloves are suitable in situations where powder is not desirable.
The Nitrile Powder-Free Medical Examination Glove (blue) is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).

Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens.
The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing fine movement necessary for treatment. The absence of natural rubber latex in the product yields no latex protein allergens.
Nitrile rubber is known to create a superior barrier to bloodborne pathogens and body fluids.

The provided document describes a 510(k) submission for Blue Nitrile Powder-Free Medical Examination Gloves. This submission is for a medical device and not an AI/ML powered device, so several of the requested categories (e.g., MRMC studies, training set details, expert qualifications for AI ground truth) are not applicable.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for physical performance tests (like watertightness or general performance standards). For the safety tests (rabbit irritation and guinea pig sensitization), it indicates that the device "Passes" without providing specific sample sizes.

• Test Set Sample Size: Not explicitly stated for performance tests. Not explicitly stated for safety tests, but the results are reported as "Passes" which implies a sufficient sample was used to meet the passing criteria for the relevant tests.
• Data Provenance: The studies were conducted by Best Manufacturing Company (USA) for a device intended for the US market. The document does not specify if the safety tests involved retrospective or prospective data collection, but given they are animal studies, they would be prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as the device is a physical medical examination glove, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth on a test set. The "ground truth" for this device relies on objective, standardized physical and biocompatibility testing.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of images or data in AI/ML studies to establish ground truth or resolve disagreements. Here, the "truth" is determined by objective laboratory measurements and biological reactions (e.g., passing a rabbit irritation test).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. MRMC studies are used to evaluate diagnostic performance, often for AI-assisted image analysis. This submission is for a physical medical device (glove) and does not involve human readers or AI assistance in diagnostic tasks.

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

This is not applicable. This submission is for a physical medical examination glove, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective, standardized laboratory measurements and animal biocompatibility test results, as defined by ASTM standards for physical properties and established protocols for safety tests like rabbit irritation and guinea pig sensitization.

8. The Sample Size for the Training Set

This is not applicable. This device is not an AI/ML algorithm that requires a training set. The "development" of the glove is based on materials science and manufacturing processes, culminating in testing against established standards.

9. How the Ground Truth for the Training Set was Established

This is not applicable, as there is no training set for this type of medical device.

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