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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.

Powder Free Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

This document describes the safety and efficacy of "Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K213408) by comparing its performance to a predicate device (K192954) and established ASTM standards. The study focuses on non-clinical testing, particularly the glove's resistance to permeation by chemotherapy drugs and fentanyl citrate.

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for this device are based on meeting or exceeding the minimum breakthrough detection times for various chemotherapy drugs and fentanyl citrate, as specified by ASTM D6978-05 (Reapproved 2019). Other criteria include physical properties, dimensions, watertight integrity, residual powder, and biocompatibility.

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

• Physical Properties (Tensile Strength, Elongation): Sample size not explicitly stated for individual tests, but implied to be sufficient for ASTM standards.
• Dimension: Sample size not explicitly stated.
• Water Tight: Sample size of 500 pieces (based on AQL level M for a batch of 500,001 or more).
• Residual Powder: Sample size of 5 pieces.
• Permeation by Chemotherapy Drugs and Fentanyl Citrate: Sample size not explicitly stated, but tests were performed per ASTM D6978-05.
• Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity): Sample sizes for the animal testing are not explicitly reported in this summary, but the results indicate standard testing procedures were followed.
• Data Provenance: The standard testing was conducted by Meditech Gloves Sdn Bhd, located in Malaysia. The study is a non-clinical study assessing the device's characteristics against recognized standards. It is implicitly a prospective evaluation for regulatory submission.

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

This document describes non-clinical laboratory testing. There is no indication of human experts establishing "ground truth" for the test set in the way a clinical study would involve expert readers. The ground truth is defined by the objective measurement criteria within the ASTM and ISO standards used (e.g., specific permeation detection limits, physical property thresholds, AQL levels).

4. Adjudication Method for the Test Set:

Not applicable. This is a non-clinical device test where results are determined by objective measurements against established standard criteria, not by human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This device is a patient examination glove, and the study focuses on its material and barrier properties, not on diagnostic accuracy involving human readers. Therefore, an MRMC study was not performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a physical medical device (glove), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth for this study is based on predefined technical specifications and validated test methodologies outlined in international standards such as:

• ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• ASTM D6978-05 (Reapproved 2019) (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
• ASTM D412-16 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension)
• ASTM D3767-03(2020) (Standard Practice for Rubber—Measurement of Dimensions)
• ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124-06 (2017) (Standard Test Method for Residual Powder on Medical Gloves)
• ISO 10993-10:2010 (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 10993-11:2017 (E) (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity)

The performance of the gloves is directly measured against the quantitative and qualitative acceptance criteria specified in these standards.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set. The device is a physical product whose performance is evaluated through material and chemical barrier integrity tests.

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.

Powder Free Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

The provided document is a 510(k) premarket notification for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue). This is a medical device of Class I and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI/ML algorithm.

Therefore, the requested information about AI model acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets is not applicable to this document.

The document describes the acceptance criteria and device performance as they relate to the physical and biocompatibility characteristics of the examination gloves. Here's a summary based on the provided text:

1. Acceptance Criteria and Reported Device Performance for Powder Free Nitrile Patient Examination Gloves

The acceptance criteria for these medical gloves are primarily based on established ASTM (American Society for Testing and Materials) and ISO standards. The reported device performance is compared against these standards and the predicate device.

Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for Testing and Data Provenance

The sample sizes for testing are defined by the specific ASTM standards followed.

• Physical Properties (Tensile Strength, Elongation): Not explicitly stated, but typically these tests involve a specified number of specimens per batch or test run according to ASTM D412.
• Watertight (Hole Detection): Sample size of 315 pieces for a batch sampling of 150,001 to 500,000 gloves, based on Inspection Level GI and AQL 1.5. This is a prospective test conducted on manufactured gloves.
• Powder Free (Residual Powder): Sample size of 5 pieces.
• Biocompatibility Tests (Skin Irritation, Sensitization, Cytotoxicity, Systemic Toxicity): These tests are typically conducted on animal models (e.g., mice, rabbits) and cell cultures. The counts of animals (e.g., number of test group animals vs. control group animals) are not explicitly stated in this summary, but the results (e.g., "no mortality," "no erythema") indicate biological testing. This data would be prospective from laboratory testing.
• Data Provenance: The manufacturing company is Meditech Gloves Sdn Bhd, Malaysia. The tests described are laboratory and quality control tests conducted as part of the manufacturing and regulatory submission process.

3. Number of Experts and Qualifications for Ground Truth

This type of medical device submission (examination gloves) does not involve human expert interpretation of images or complex diagnostic data like an AI/ML device would. Therefore, there are no "experts establishing ground truth" in the diagnostic sense. The "ground truth" for the performance of these gloves is defined by the objective, quantifiable results of the standardized physical and biocompatibility tests (e.g., direct measurements of tensile strength, elongation, amount of powder, number of leaks, observed biological reactions in laboratory tests).

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The tests are objective and quantitative.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML diagnostic device that interacts with human readers or interprets medical cases.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a physical examination glove, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for this device is based on objective, quantitative measurements and laboratory test results against established international standards (ASTM, ISO) for material properties, physical dimensions, leak detection, and biocompatibility.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML 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 an AI/ML algorithm, the concept of establishing ground truth for it does not apply here.

In summary, the provided document is a regulatory submission for a physical medical device (examination gloves) where "acceptance criteria" relate to meeting specific physical and biological performance standards, not to the performance of an AI/ML algorithm.

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