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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 (green) 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 text describes a 510(k) submission for a Green Nitrile Powder-Free Medical Examination Glove. This is a medical device, and the submission's purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove clinical efficacy through the types of studies typically associated with AI/ML devices. Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For examination gloves, the primary performance criteria relate to barrier integrity, safety (biocompatibility), and physical properties. The document indicates adherence to ASTM standards for physical performance and includes biocompatibility testing.

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

• Test Set Sample Size: Not explicitly stated for specific tests like watertightness or biocompatibility. However, these are typically performed on representative samples according to the relevant ASTM standards.
• Data Provenance: Not specified; likely laboratory testing conducted by or for the manufacturer.

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

Not applicable. For examination gloves, performance is assessed through standardized physical and chemical tests, not through expert-labeled ground truth like in AI/ML image analysis.

4. Adjudication method for the test set

Not applicable. The "ground truth" for the performance characteristics of medical examination gloves is determined by objective, standardized tests, not by expert consensus or adjudication.

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

For the safety and performance aspects:

• Watertightness and Performance Standards: Objective measurements against American Society for Testing and Materials (ASTM) standards.
• Safety (Biocompatibility): Established "Pass/Fail" criteria based on animal testing (Rabbit Irritation, Guinea Pig Sensitization) as per biocompatibility guidelines.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set" in the context of developing this type of medical examination glove.

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

Not applicable.

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