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Disposable Medical Nitrile Examination Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile). The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I) for single use only. The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided document is a 510(k) Premarket Notification for Disposable Medical Nitrile Examination Gloves (Non-Sterile). This type of document is for a medical device that does not use AI/ML, and therefore, the requested information regarding AI/ML device performance and related study details is not applicable.

However, I can extract the acceptance criteria and performance data for this device based on the non-clinical testing summary provided.

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable Medical Nitrile Examination Glove is 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.

The provided text describes the acceptance criteria and the study conducted for a medical device: "Disposable Medical Nitrile Examination Gloves (non-sterile)." This is a Class I medical device, and the study focused on non-clinical tests to demonstrate substantial equivalence to a predicate device, rather than the types of studies typically performed for AI/ML-based diagnostic devices. Therefore, many of the requested categories are not applicable.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of data for an AI/ML device. The tests performed are for medical gloves and involve physical and biological property assessments, not analysis of data from patients or images. The provenance of the samples (e.g., country of origin for the gloves tested) is not specified beyond the manufacturer's location (China). These were non-clinical tests.

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

Not applicable. The ground truth for the physical and biological properties of the gloves is established by standardized testing protocols (ISO, ASTM) and measurements, not by expert interpretation of data relevant to AI/ML.

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

Not applicable. As noted above, the tests are for physical and biological properties of gloves, not for AI/ML performance requiring adjudication of interpretations.

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 device is a medical glove, not an AI-based diagnostic tool. No MRMC study was conducted.

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

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

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

The ground truth for the non-clinical tests is based on objective measurements and established standards for material properties (e.g., tensile strength, elongation), dimensional specifications (e.g., length, width, thickness), and biocompatibility assays (e.g., cytotoxicity, irritation, sensitization, systemic toxicity).

8. The sample size for the training set

Not applicable. This device does not involve an AI/ML algorithm requiring a training set.

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

Not applicable. This device does not involve an AI/ML algorithm.

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Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves, Non-sterile. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

The document describes the acceptance criteria and study proving the device meets them for Disposable Medical Nitrile Examination Gloves (Non-Sterile) (K211075).

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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