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Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution

This document is a 510(k) clearance letter from the FDA for a new medical device, specifically examination gloves. It does not describe an AI/ML powered device, and therefore the majority of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not applicable.

However, I can extract the relevant "acceptance criteria" for the gloves in terms of their resistance to chemotherapy drugs and other solutions, as presented in the document:

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

The acceptance criteria for these gloves are implicitly defined by their performance against the listed chemicals, demonstrating their barrier effectiveness by reporting breakthrough times according to ASTM D6978-05 (2019). The goal is to show a reasonably long breakthrough time for protection. While specific pass/fail thresholds are not explicitly stated as "acceptance criteria" in a quantitative sense here, the reported times indicate the device's protective capabilities.

Note: The document explicitly highlights lower breakthrough times for Carmustine and Thiotepa as a "CAUTION," indicating these values are notable and potentially below a desired threshold, though a hard "failure" isn't stated for regulatory clearance.

The rest of the requested information (points 2-9) is not applicable to this document because it describes a physical medical device (examination gloves), not an AI/ML-powered software. Therefore, there is no mention of:

• Sample size used for an AI test set or data provenance.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for an AI model.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth (beyond chemical testing results).
• Training set size or how its ground truth was established.

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I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for "Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors," indicating that the device is substantially equivalent to a legally marketed predicate device.

The information you are asking for, such as:

• A table of acceptance criteria and reported device performance
• Sample size and data provenance for the test set
• Number and qualifications of experts for ground truth establishment
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Training set sample size and ground truth establishment

...are typically found in detailed regulatory submissions or scientific studies, which are not present in this FDA clearance letter. This letter primarily focuses on the regulatory equivalence determination.

Ask a specific question about this device