Search Results

Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

Dainam JSC., Powder Free Gloves are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile- butadiene copolymer dispersion. These gloves are blue in color and are powder free, non-sterile, single use and disposable and available in size XS-extra small, S-small, M-medium, L-Large, XL- Extra-large.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device (Powder Free Nitrile Examination Glove). It details the device's characteristics, intended use, and a comparison to a predicate device, along with non-clinical testing results.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists test methods (e.g., ASTM D6319-2019, ISO 10993 series) but does not specify the sample sizes used for each test for the subject device. It also does not specify the data provenance in terms of country of origin or whether the tests were retrospective or prospective. It only indicates that "Non-clinical tests were conducted to verify that the proposed device complies with the following standards".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a medical examination glove, which is a physical device, not an AI or diagnostic imaging product. Therefore, the concept of "experts" establishing a "ground truth" for a test set in the way it's described (e.g., radiologists for medical images) does not apply to this type of device. Performance is measured against established material and safety standards.

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

The concept of an "adjudication method" (like 2+1 or 3+1 consensus) is relevant for studies involving human interpretation of data, particularly in diagnostics or AI algorithm validation. Since this document pertains to the physical and biocompatibility testing of a medical glove, this method is not applicable and not mentioned.

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

This is a physical medical device (examination glove), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed.

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

Again, this is a physical medical device. The concept of "standalone algorithm performance" does not apply. The tests performed are on the physical and chemical properties of the glove itself.

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

For this type of device, "ground truth" is defined by the established ASTM and ISO standards for physical properties (like length, width, thickness, tensile strength, elongation, watertightness, powder residue) and biocompatibility (irritation, sensitization, cytotoxicity, systemic toxicity, pyrogenicity). These standards themselves represent a consensus on what constitutes acceptable performance for such a device.

8. The sample size for the training set

This is a physical medical device, not an AI algorithm. Therefore, the concept of a "training set" for machine learning does not apply and no training set was used.

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

As there is no training set for this type of device, this question is not applicable.

Ask a specific question about this device