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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 specially glove has also been tested with Chemotherapy drugs and the Opioid Fentanyl citrate.

The K212613 gloves are produced as nitrile synthetic gloves. They are manufactured without natural rubber latex. The nitrile gloves are blue in color, disposable, single-use only, non-sterile, medical examination gloves. K212613 meets all the requirements of ASTM D6978-10(2019) Standard Specifications for Examination Gloves for Medical Applications. They have been tested for use with chemotherapy drugs and the opioid Fentanyl citrate, both of which were evaluated using ASTM D6378-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The provided document describes the acceptance criteria and performance of Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue). The evaluation is based on non-clinical performance tests, not clinical studies involving human or animal subjects. Therefore, sections related to human reader studies, ground truth establishment by experts, and training set information are not applicable.

Here's the information extracted from the document:

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 the exact sample sizes (e.g., number of gloves) used for each non-clinical test. The tests are standard industry tests (e.g., ASTM, ISO standards) typically performed by manufacturers and independent labs. The data provenance is from the manufacturer's testing (Koon Seng Sdn. Bhd. located in Malaysia) or accredited laboratories performing these standard tests. These are non-clinical, controlled laboratory tests, not retrospective or prospective clinical data.

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

This is not applicable as the evaluation is based on objective, non-clinical laboratory tests according to specified standards, not expert interpretation of outputs like in AI/imaging studies.

4. Adjudication method for the test set

This is not applicable as the evaluation is based on objective, non-clinical laboratory tests.

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

No such study was done. This device is an examination glove, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a physical product (gloves), not an algorithm. The tests performed are standalone evaluations of the glove's physical and chemical resistance properties.

7. The type of ground truth used

The "ground truth" for the performance criteria is defined by established international and national standards for medical gloves (e.g., ASTM D6978, ASTM D412, ASTM D5151, ASTM D6124, ISO 10993). These standards specify the test methodologies and acceptable limits for physical properties, chemical permeation, and biocompatibility.

8. The sample size for the training set

This is not applicable as this is not a machine learning or AI device.

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

This is not applicable as this is not a machine learning or AI device. The "ground truth" for the performance of the gloves is established by adherence to the objective criteria and methods outlined in the mentioned ASTM and ISO standards for medical devices and materials.

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Powder Free Nitrile Examination. Gloves, Non -Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hands of finger to prevent contamination between patient and examiner.

The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Icct.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details:

Based on the provided document, the device in question is a medical glove, a Powder Free Nitrile Examination Glove, Blue, Non Sterile. The document describes a non-clinical performance study and explicitly states that clinical data is not needed for gloves or for most devices cleared by the 510(k) processes.

Therefore, most of the requested information for a typical medical AI device study (sections 2, 3, 4, 5, 6, 7, 8, 9) is not directly applicable or available in this context. Here's what can be inferred:

1. A table of acceptance criteria and the reported device performance:

• This is provided in the first table above, extracted directly from the document.

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

• Sample Size: Not explicitly stated for each test. The tests are for manufacturing quality control (e.g., pinholes, dimensions, physical properties, powder residue) and biocompatibility. For manufacturing tests, samples would be taken from production batches. For biocompatibility, animal testing (rabbits) was used.
• Data Provenance: The tests are likely conducted by the manufacturer, PT. MAHAKARYA INTI BUANA, based in SUMUT - INDONESIA. The exact country of origin of the data is Indonesia, as it's a submission from an Indonesian company.
• Retrospective or Prospective: These are likely prospective tests performed on the manufactured product to ensure compliance with standards.

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

• Not applicable in the context of device performance testing for medical gloves. The "ground truth" is established by the specified ASTM and FDA standards for physical and chemical properties and laboratory animal testing for biocompatibility. These standards define the objective criteria.

4. Adjudication method for the test set:

• Not applicable. Performance against defined objective standards (ASTM, FDA) for physical and chemical properties does not involve human adjudication in the same way clinical image interpretation might. Biocompatibility testing follows established laboratory protocols.

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 a medical glove, not an AI-powered diagnostic device.

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

• Not applicable. This is a medical glove, not an AI-powered device. The "device performance" reported is the standalone performance of the glove itself against physical and chemical standards.

7. The type of ground truth used:

• Objective Standards: The ground truth for dimension, physical properties, freedom from pinholes, and powder residue is based on the objective criteria defined in the respective ASTM standards (D 6319-00aE3, D 6319-00aF3, D 6124 - 01) and FDA regulations (21 CFR 800.20 for water leak test).
• Biocompatibility Testing Protocols: For biocompatibility (Primary Skin Irritation and Dermal Sensitization), the ground truth is established by the results of standardized animal (rabbit) testing protocols, where "Passes" means "No primary skin irritation" and "No contact sensitizer."

8. The sample size for the training set:

• Not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The manufacturing process is refined, but this is not a training set in the AI sense.

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

• Not applicable for the reasons stated above.

In summary, the provided document focuses on demonstrating substantial equivalence for a medical glove through non-clinical performance data against established industry standards and regulatory requirements. It explicitly states that clinical data is not required for this type of device within the 510(k) pathway.

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