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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powder-free class I Nitrile Patient Examination Gloves which coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs. The subject devices are identical in design and formulation to the predicate gloves of K230121.

The provided FDA 510(k) clearance letter pertains to Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black), a medical device. This type of device is classified as a Class I medical device and does not involve AI/ML technology. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance, expert qualifications, adjudication methods, effect sizes) are not applicable.

The acceptance criteria and device performance are primarily evaluated based on material properties, chemical permeation resistance, and biocompatibility, using established ASTM and ISO standards for examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The device, "NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK)", was tested against various physical, chemical, and biological criteria.

Detailed Chemotherapy Drug and Fentanyl Citrate Permeation Performance:

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

The document does not explicitly state the exact sample sizes for each test (e.g., number of gloves tested for permeation, holes, dimensions, etc.) but refers to adherence to the methodologies outlined in the specified ASTM and ISO standards. These standards typically define minimum sample sizes for material testing.

• Data Provenance: The document states the applicant is from Malaysia (Careglove Global Sdn. Bhd.). The testing was conducted according to international standards (ASTM, ISO), implying the tests were performed in a controlled laboratory environment, likely by the manufacturer or a contracted lab. The data is non-clinical and derived from prospective testing of manufactured glove samples.

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

Not applicable. This device is not an AI/ML device that requires expert review for "ground truth" establishment in the context of diagnostic or interpretive tasks. The "ground truth" for material properties is established by the physical and chemical measurements themselves, according to standardized protocols and certified laboratory equipment.

4. Adjudication Method for the Test Set

Not applicable. This device is not an AI/ML device that requires adjudication for interpretations. Test results are objective measurements against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. MRMC studies are relevant for diagnostic or interpretive AI/ML devices where human readers' performance is evaluated with and without AI assistance. This is a physical and chemical barrier device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. This device is a passive physical barrier and does not involve any algorithms or software.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements of physical properties (e.g., length, thickness, tensile strength, elongation), chemical resistance (breakthrough detection time), and biological reactivity (biocompatibility tests), as defined by internationally recognized standards (ASTM, ISO). There is no subjective human "ground truth" in this context.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that undergoes "training."

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

Not applicable. This is not an AI/ML device. The manufacturing process of the gloves is designed to meet the specified standards, and quality control ensures consistency, but this is not "training" in the context of AI/ML.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powderfree variation of the class I Nitrile Patient Examination Gloves which is coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs and Fentanyl Citrate.

This document describes the testing for Nitrile Examination Gloves, focusing on their resistance to chemotherapy drugs and Fentanyl Citrate. The study assesses the gloves' physical properties, biocompatibility, and chemical permeation alongside the reported device performance.

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy and Fentanyl Citrate Permeation (Minimum Breakthrough Detection Time)

Physical Properties, Dimensional, and Biocompatibility Testing

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

The document does not explicitly state the sample size (number of gloves) used for the permeation, physical property, or biocompatibility tests.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, the tests were conducted according to international standards (e.g., ASTM, ISO), which implies a standardized, prospective testing approach in a laboratory setting. The applicant is based in Malaysia.

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

Not applicable. This is not a study involving expert readers or ground truth established by medical professionals. The "ground truth" for this device is determined by objective, standardized laboratory measurements (e.g., chemical permeation time, physical properties, biological reactions) as defined by the referenced ASTM and ISO standards.

4. Adjudication Method for the Test Set

Not applicable. There was no human adjudication process involved as the "ground truth" is determined by objective laboratory measurements and adherence to specified test standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The device in question is examination gloves, and its performance is evaluated through physical, chemical, and biological testing, not by human readers interpreting cases.

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

Not applicable. This is a medical device (examination gloves), not an AI algorithm. Therefore, the concept of "standalone" performance for an algorithm does not apply. All listed tests are "standalone" in the sense that they assess the intrinsic properties of the glove without human intervention in the measurement process itself, though human technicians conduct and analyze the tests.

7. The Type of Ground Truth Used

The ground truth used for this study is based on:

• Performance Standards: Defined by international standards such as ASTM D6978-05 (for chemotherapy drug permeation), ASTM D6319-19, ASTM D5151-19, ASTM D6124-06 (for physical properties and hole freedom), and ISO 10993-10, ISO 10993-5:2009, ISO 10993-11 (for biocompatibility).
• Objective Laboratory Measurements: Direct measurements of breakthrough time, dimensional properties, tensile strength, elongation, residual powder, and biological response to the glove materials.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned or implied in this submission, as the device is not an AI/ML algorithm that requires training data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.

This is a 510(k) summary for a medical device (Powder Free Nitrile Examination Gloves, Blue, Chemotest), not an AI/ML device. Therefore, the sections regarding AI/ML device assessment criteria (such as sample size for test/training set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.

Here's the relevant information extrapolated from the document regarding acceptance criteria and performance:

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 explicitly state the sample sizes for each non-clinical test (e.g., number of gloves tested for dimensions, holes, or physical properties). However, it implies that the testing was conducted according to the specified ASTM and ISO standards, which would dictate appropriate sample sizes for each test method.

The data provenance is not explicitly stated in terms of country of origin of the testing data itself, but the applicant is Careglove Global SDN BHD from Malaysia. The studies are non-clinical, laboratory-based tests.

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

Not applicable, as this is for a physical medical device (examination gloves) and not an AI/ML diagnostic or predictive device requiring ground truth from human experts. The "truth" is established by physical measurement against standard specifications.

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

Not applicable. This concept applies primarily to AI/ML clinical studies where human readers might adjudicate discrepancies or define ground truth. For physical device testing, results are measured and compared against established 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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

The "ground truth" or reference values for device performance are defined by recognized international and national standards:

• ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124-06 (Standard Test Method for Residue on Medical Gloves)
• ASTM D6978-05 (Standard Practice for Assessment 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 10993-5:2009 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
• ISO 10993-11 (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity)

The device's performance is compared directly to the specifications outlined in these standards.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device and therefore does not have a "training set."

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

Not applicable, as this is not an AI/ML device and therefore does not have a "training set" with established ground truth.

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