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A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the hand or finger to prevent contamination between examiner and patient.

Powder Free Nitrile Examination Glove, Non-sterile (Blue)

This document is an FDA 510(k) clearance letter for Powder Free Nitrile Examination Gloves. It does not contain any information about an AI/ML medical device, acceptance criteria, or performance study data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The information requested (e.g., sample sizes, expert qualifications, ground truth, MRMC studies) is relevant to the evaluation of AI/ML devices, not to a simple medical device like examination gloves.

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A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested for use with Chemotherapy Drugs and the Opioid Fentanyl citrate, simulated Gastric Acid and Fentanyl in Gastric Acid.

Powder Free Nitrile Examination Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)

The provided text describes the indications for use and performance of Powder Free Nitrile Examination Gloves, specifically tested for chemotherapy drugs and fentanyl. This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study report that would typically detail acceptance criteria and a study design for a new device's performance.

Therefore, the information required to fully answer your request regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not present in this document. This document primarily presents the results of testing the gloves against various substances.

However, I can extract the reported device performance from the provided tables, which can be interpreted as demonstrating that the device met certain performance criteria for breakthrough detection times. The implicit acceptance criterion for most of the listed substances appears to be "no breakthrough up to 240 minutes."

Here's a breakdown based on the available information:

1. Table of acceptance criteria and the reported device performance

Note: The acceptance criterion of "No breakthrough up to 240 minutes" is inferred from the reported performance for most substances. For Carmustine and ThioTepa, the low breakthrough times are explicitly called out as a warning, indicating they do not meet the implied 240-minute resistance for other drugs/substances.

The following information is NOT available in the provided document:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document does not specify the number of gloves tested for each substance or the origin/type of data collection. This is typical for a 510(k) summary, which often references testing standards (e.g., ASTM standards for glove permeability) rather than detailing the full study protocol.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A, as this is a physical barrier test, not an assessment requiring expert interpretation of complex data (like medical imaging). The "ground truth" would be the chemical breakthrough itself, detected by analytical methods.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
• 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: N/A. This is not an AI or diagnostic imaging device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this type of device, the "ground truth" is the objective measurement of chemical breakthrough time, typically determined by standardized laboratory methods (e.g., in accordance with ASTM D6978 for chemotherapy drugs).
• The sample size for the training set: N/A. There is no AI or machine learning component that would require a training set.
• How the ground truth for the training set was established: N/A.

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