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The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

"Disposable Powder Free Nitrile Examination Glove, Pink Color" and "Disposable Powder Free Nitrile Examination Glove, Black Color" are patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This document is a 510(k) summary for a disposable powder-free nitrile examination glove, and as such, it focuses on demonstrating substantial equivalence to a predicate device based on bench testing. It does not describe an AI medical device, and therefore, many of the requested elements for AI/ML evaluation (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance of an algorithm) are not applicable.

However, I can extract the acceptance criteria and reported device performance from the provided text for the physical characteristics of the glove.

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance
The document refers to "bench testing" and compliance with ASTM standards and ISO standards. These standards typically involve specific sample sizes and testing methodologies defined within the standard itself. The document does not explicitly state the exact number of units tested for each specific criterion. Data provenance is not specified beyond "bench testing" implies laboratory testing of the physical product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device (nitrile examination glove) and not an AI/ML medical device where expert ground truth for interpretation would be required. The "ground truth" here is the pass/fail result against established material and performance standards.

4. Adjudication method for the test set
Not applicable, as this is bench testing of physical properties against established standards, not an AI output requiring expert 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 medical device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI medical device.

7. The type of ground truth used
The "ground truth" for the device's performance is based on established national and international standards for medical gloves, specifically:

• ASTM D6319-10 (Reapproved 2015) - Standard specification for Nitrile Examination Gloves
• 21 CFR 800.20 - Freedom from holes
• ASTM D5151-06 (Reapproved 2015) - Test method for detection of holes in medical gloves
• ASTM D6124-06 (Reaffirmation 2011) - Test method for residual powder on medical gloves
• ISO 10993-10: Third Edition 2010-08-01 - Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
• ISO 10993-5: Third Edition 2009-06 - Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

8. The sample size for the training set
Not applicable. This is not an AI medical device.

9. How the ground truth for the training set was established
Not applicable. This is not an AI medical device.

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