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A disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.

Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner and for use handling chemotherapy drugs.

This document is a 510(k) Pre-Market Notification for the Nitra-Touch™ examination gloves. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" and rather references compliance with existing ASTM standards and internal tests. Information regarding sample sizes for each specific test (e.g., freedom from holes, tensile strength, puncture resistance, biocompatibility) is not provided. The data provenance is implied to be from internal testing conducted by Ansell Edmont Industrial, Inc. and potentially third-party labs like TRI/Environmental, Inc. for the glutaraldehyde resistance. The data is presented as retrospective as it's being submitted for current product clearance against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to this submission. The "ground truth" for the performance characteristics of medical examination gloves is established by the specified ASTM (American Society for Testing and Materials) standards and FDA requirements. The tests are physical and chemical measurements against these quantitative standards, not subjective assessments requiring expert consensus for ground truth.

4. Adjudication method for the test set

This is not applicable. As stated above, the performance is measured against established quantitative standards, not through subjective 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

There is no MRMC comparative effectiveness study mentioned or implied. This device is a physical medical glove and does not involve AI or human "readers" in the context of diagnostic interpretation.

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

This is not applicable. The device is not an algorithm or AI system.

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

The ground truth used for evaluating the Nitra-Touch™ examination gloves is based on established industry standards (ASTM) and regulatory requirements (FDA) for medical examination gloves. These standards define specific physical and chemical properties (e.g., dimensions, strength, freedom from holes, biocompatibility) with quantitative pass/fail criteria.

8. The sample size for the training set

This is not applicable. This is a submission for a physical medical device (gloves) and does not involve a "training set" in the context of machine learning or AI models. The manufacturing processes and quality control would involve statistical sampling, but this is distinct from a "training set" for an algorithm.

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

This is not applicable for the reasons stated in point 8.

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Nitra-Touch™ examination gloves are disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Nitra-Touch™ examination gloves

This document describes the acceptance criteria and performance of Nitra-Touch™ examination gloves, specifically focusing on their compliance with ASTM standards and other relevant criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size 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 exact sample sizes used for each individual test (e.g., number of gloves tested for holes, tensile strength, etc.). The mention of "non clinical tests" suggests these are laboratory-based evaluations.

The data provenance is not explicitly stated in terms of country of origin. The testing for Glutaraldehyde Resistance was performed by "TRI/Environmental, Inc.", which is likely a US-based laboratory, but this is not definitively stated as the origin of all data. The study appears to be prospective in nature, as new glove samples would be manufactured and tested against predefined standards.

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)

This section is not applicable as the document describes the performance of a physical product (examination gloves) against established laboratory standards (ASTM standards and other performance metrics) rather than the interpretation of medical images or data requiring expert consensus or ground truth in the context of AI or diagnostics. The "ground truth" here is the physical measurement and chemical testing results according to the specified test methods.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI evaluations where multiple human readers review data and discrepancies need to be resolved. For laboratory testing of physical products, the results are derived directly from the test methodology, and repeatability/reproducibility are typically addressed within the standard itself.

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 section is not applicable. This document describes the performance of a medical device (examination gloves) through laboratory testing, not an AI system. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

This section is not applicable. This document describes the performance of a medical device (examination gloves), not an algorithm or AI system.

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

The "ground truth" for the performance of the Nitra-Touch™ examination gloves is based on:

• Established ASTM Standards and Test Methods: These standards define specific procedures and criteria for evaluating properties like dimensions, physical properties (tensile strength, elongation), freedom from holes, and tensile strength (ASTM D 3578, ASTM D 5250, ASTM D 5151, ASTM D 120-87, ASTM T F739-91).
• Laboratory Measurements and Chemical Analyses: The performance metrics (e.g., MPa for tensile strength, lbf/in for puncture resistance, breakthrough time for chemical resistance, mg residue by mass) are direct results of these standardized tests.
• Biocompatibility Testing Protocols: "Passes" for Primary Skin Irritation and Guinea Pig Sensitization indicate adherence to established biological safety testing protocols for medical devices.

8. The sample size for the training set

This section is not applicable. There is no "training set" in the context of evaluating the performance of physical examination gloves. This concept applies to machine learning models, not physical product testing.

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

This section is not applicable for the same reasons as point 8.

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