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Rhino Non-Sterile Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are as follows:

Note: Carmustine and Thiotepa have extremely low permeation times of 14.2 and 43.2 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa

Rhino Non-sterile Powder-Free Nitrile Exam Glove - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in two sizes, medium and large. The color for all sizes is periwinkle. The model number is RHI-UNB5 with specific part sizes based on size as follows:

The provided text is a 510(k) Summary for a medical device: "Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing the extensive clinical study data one would find for novel, higher-risk devices. As such, the information you're requesting regarding AI-specific criteria, human expert adjudication, and large-scale training/test data for an AI algorithm is largely not applicable to this document because it describes a physical examination glove, not an AI/ML medical device.

However, I will extract and present the available information related to acceptance criteria and the "study" (non-clinical testing) that proves the device meets them, while also clearly indicating what information is not present or applicable.

Acceptance Criteria and Device Performance (Non-Clinical)

The acceptance criteria for this medical glove are based on established ASTM and ISO standards for physical properties, barrier integrity, and biocompatibility, as well as an assessment for chemical permeation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported performance are derived from Section VI of the 510(k) Summary: "Comparison of Technological Characteristics with Predicate Device" and Section VII: "Non-Clinical Studies."

Note on Chemotherapy Permeation: For most chemotherapy drugs, the acceptance criteria are implicitly met by achieving a breakthrough detection time of >240 minutes. For Carmustine and Thiotepa, while permeation times are reported, the device is explicitly warned against use with these drugs, meaning the acceptance criterion for safe use with these specific drugs is effectively "not intended."

Information Not Applicable or Not Provided

The request is tailored for AI/ML device studies. This submission is for a physical medical glove. Therefore, most of the requested points are not applicable or the information is not provided in the 510(k) summary.

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

• Sample Size: Specific sample sizes for each physical test (e.g., how many gloves for tensile strength, or how many for hole detection) are not explicitly detailed beyond the general "Pass" results against AQLs (Acceptable Quality Levels) or ASTM minimums. For permeation tests, breakthrough times are given for specific (presumably triplicate or similar standardized) specimens as per ASTM D6978-05.
• Data Provenance: Not specified, but standard testing for medical devices typically occurs in specialized labs following good laboratory practices (GLP). It would be considered prospective testing for the purpose of this submission.
• Retrospective or Prospective: The testing reported is prospective, specifically performed to demonstrate conformance to standards for this 510(k) submission.

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 hardware device, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" (i.e., whether the glove meets specifications) is established through standardized laboratory testing protocols, not human expert consensus.

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

• Not Applicable. See point 3. Testing is based on objective measurements against engineering and material standards.

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-driven device. No human-in-the-loop studies or MRMC studies were conducted as part of this submission.

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

• Not Applicable. This is not an AI algorithm.

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

• Physical/Chemical Standards Compliance: The "ground truth" is compliance with established international and national standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D6978-05, ISO 10993-10, ISO 10993-11) verified through laboratory testing.

8. The sample size for the training set:

• Not Applicable. There is no AI model or training set for this product.

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

• Not Applicable. There is no AI model or training set for this product.

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