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Disposable Medical Synthetic 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 Synthetic Nitrile Examination Gloves. Non-sterile. The subject device is a patient examination glove made from nittile and vinyl 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 provided document is a 510(k) summary for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile). It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The proposed device is powder free, non-sterile nitrile examination gloves. Following FDA Code LZA, a "nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants."

This document is a 510(k) Premarket Notification for a medical device: Nitrile Glove Powder Free Blue. It seeks to demonstrate substantial equivalence to a predicate device.

The provided text describes the regulatory process, device information, and a comparison of the proposed device with a predicate device, focusing on non-clinical performance testing. It does not contain information about an AI/ML device, nor does it describe a study involving human readers or comparative effectiveness for an AI model.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study proving an AI/ML device meets those criteria, specifically concerning:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes, data provenance, and ground truth establishment for AI/ML test and training sets.
• Details on expert involvement (number, qualifications, adjudication) for an AI/ML ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI assistance.
• Stand-alone AI algorithm performance.

The document is entirely focused on the physical and chemical properties and safety of a medical glove, not an AI/ML system.

However, I can extract the acceptance criteria and performance data for the Nitrile Glove Powder Free Blue from the provided document, which pertains to its non-clinical testing.

Here's a breakdown of the acceptance criteria and results for the medical glove as presented in the document:

1. A table of acceptance criteria and the reported device performance (for the physical glove)

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

The document does not specify the exact sample sizes (number of gloves) used for each non-clinical test. It only states the tests were conducted. The data provenance is implied to be from the manufacturer's internal testing or accredited labs in China (Changzhou Universal Medical Equipment Co. Ltd. is located in Changzhou, Jiangsu Province, China). The tests are retrospective in the sense that they were performed on finished products.

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

Not applicable to this type of non-clinical testing for a medical glove. The "ground truth" for these tests is established by standardized laboratory methods (e.g., measuring dimensions, performing leak tests, chemical assays for cytotoxicity) according to the specified ISO, ASTM, and EN standards. These are objective measures, not requiring expert consensus or interpretation in the same way an AI model's output would.

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

Not applicable. As noted above, these are objective physical and biological tests, not requiring adjudication of human performance or AI output.

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 document is for a medical glove, not an AI/ML device. No human reader studies were conducted or relevant.

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

Not applicable. This is not an AI algorithm. The performance described is the standalone performance of the physical glove.

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

The "ground truth" for the glove's performance is based on the results of standardized laboratory engineering and biological tests as defined by ISO, ASTM, and EN standards (e.g., presence/absence of leaks, specific measurements (length, width, thickness), tensile strength, elongation, cytotoxicity, irritation, sensitization).

8. The sample size for the training set:

Not applicable. There is no training set for a physically manufactured medical glove in the context of an AI/ML model.

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

Not applicable. There is no training set as this is not an AI/ML device.

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