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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:

Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 14.2
Cisplatin (1.0 mg/mL 1,000 ppm) > 240
Cyclophosphamide (Cytoxan) (20 mg/mL 20,000 ppm) > 240
Dacarbazine (10 mg/mL 10,000 ppm) > 240
Doxorubicin Hydrochloride (2.0 mg/mL 2,000 ppm) > 240
Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) > 240
Flurouracil (50.0 mg/mL 50,000 ppm) > 240
Paclitaxel (Taxol) (6.0 mg/mL 6,000 ppm) > 240
Thiotepa (10.0 mg/mL 10,000 ppm) 43.2
Fentanyl Tested as Follows:
Fentanyl Citrate Injection (100 mcg/2mL) > 240

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 three sizes, extra small, small, and extra 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 document describes the acceptance criteria and study results for the "Rhino Non-sterile Powder-Free Nitrile Exam Glove - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl." This is a medical device, and the criteria relate to its physical properties, biocompatibility, and resistance to chemotherapy drugs and Fentanyl.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and the Data Provenance:

The document outlines that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." However, specific sample sizes for each test are generally not explicitly stated with numerical values in the provided summary beyond "3 specimens" for the permeation test and "50," "100," or "150" gloves for "Freedom from holes" for the predicate device. For example, for "Freedom from holes" for the subject device: "XS: No leakers in 50, S: 3 leakers in 100, XL: No leakers in 50."

The data provenance is from non-clinical laboratory studies conducted to evaluate the device's adherence to various ASTM and ISO standards for medical gloves. The studies are prospective in nature, as they involve testing the manufactured device against established standards. The country of origin of the data is not specified in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not applicable to this type of device and study. The "ground truth" for the performance of these examination gloves is established by adherence to recognized industry standards (ASTM, ISO). There are no human "experts" establishing a subjective ground truth in the way there would be for a diagnostic AI device. The tests are objective measurements and assessments against predefined physical, chemical, and biological criteria.

4. Adjudication Method for the Test Set:

This is not applicable. As mentioned above, the "ground truth" is determined by objective measurements compared to established standard criteria, not by human interpretation requiring adjudication.

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 not applicable. This document describes the testing of a physical medical device (nitrile exam gloves), not an artificial intelligence (AI) or software-as-a-medical-device (SaMD) that would involve human readers or AI assistance.

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

This is not applicable. This document describes the testing of a physical medical device (nitrile exam gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth is established by adherence to internationally recognized standards and specifications for medical gloves. These include:

• ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
• ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs)
• ISO 10993-10 (Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
• ISO 10993-11 (Biological evaluation of medical devices - Part 11: Tests for Systemic Toxicity)

For the chemotherapy drug permeation test, a "minimum breakthrough detection time of >240 min on all three (3) specimens" is described as the expectation, although the nature of the test is to determine the permeation, not necessarily to meet a strict pass/fail for all drugs (as evidenced by the warning for Carmustine and Thiotepa). Therefore, the ground truth is based on the objective measurements derived from these standardized test methodologies.

8. The Sample Size for the Training Set:

This is not applicable. This filing is about a physical medical device, not a machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

This is not applicable for the same reason as above.

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