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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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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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Rhino Non-Sterile Powder-Free Nitrile Patient Exam Glove - Blue 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 Rhino Non-Sterile Powder-Free Nitrile Exam Gloves – Blue 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.

This document describes the performance of a medical glove, not an AI device. Therefore, several requested categories are not applicable. Here's a breakdown of the requested information based on the provided text, focusing on the glove's performance:

1. 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)

• Sample Size for Physical Tests (ASTM D6319):
  • Freedom from holes: 50 gloves for Medium size, 50 and 100 gloves for Large size. (Implies multiple samples were taken and tested to demonstrate this AQL).
  • Specific sample sizes for other D6319 tests (Ultimate elongation, Tensile strength, Thickness, Palm Width, Length, Powder-Free) are not explicitly stated by number, but assumed to be sufficient for ASTM standard compliance, likely involving multiple gloves per size.
• Sample Size for Chemotherapy Permeation (ASTM D6978): Not explicitly stated, but per ASTM D6978, at least three specimens (gloves) should be tested for breakthrough time for each chemical.
• Sample Size for Biocompatibility (ISO 10993-10, ISO 10993-11):
  • ISO 10993-11 Systemic Toxicity: "Albino Swiss mice" (number not specified, but typically multiple mice per extract and control group).
  • ISO 10993-10 Primary Skin Irritation: "New Zealand white rabbits" (number not specified, but typically multiple rabbits).
  • ISO 10993-10 Guinea Pig Sensitization: "test animals" (number not specified, but typically multiple guinea pigs).
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Non-clinical testing typically involves prospective laboratory studies.

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)

Not applicable. This is a non-clinical performance evaluation of a physical device against established ASTM and ISO standards, not an AI device requiring human expert ground truth for interpretation. The "ground truth" here is the measurement against the specified standard criteria.

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

Not applicable. This is a non-clinical performance evaluation against standardized laboratory tests; there is no human interpretation or adjudication in the sense of comparing opinions. The results are quantitative measurements against objective criteria specified by the 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 document pertains to a medical glove, not an AI device.

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

Not applicable. This document pertains to a medical glove, not an AI device.

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

The "ground truth" for the device's performance is defined by adherence to established international and national standards for medical gloves and testing protocols:

• ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM D6978-05: Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
• ISO 10993-11: Biological Evaluation of Medical Devices - Part 11: Test for Systemic Toxicity
• ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization

These standards specify the methodologies, acceptance/rejection criteria, and measurement techniques. The "ground truth" is therefore derived from the objective measurements obtained through these standardized tests.

8. The sample size for the training set

Not applicable. This document pertains to non-clinical testing of a physical device, not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for a medical device that is not AI/ML based.

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