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The Glide-On Vinyl Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

The Glide-On Vinyl Examination Gloves are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free and are made of polyvinyl chloride (PVC) with an inner coating of polyurethane. This inner polyurethane coating acts as a lubricant to aid in the donning of the gloves when hands are wet, damp or dry. The gloves are offered non-sterile and are available in small, medium, large and extra large sizes.

The document describes the acceptance criteria and the study conducted for Medline Industries, Inc.'s "Glide-On Vinyl Examination Gloves" (K151754).

1. Table of Acceptance Criteria and Reported Device Performance:

Biocompatibility Testing:

• Irritation: Complies with ISO 10993-10: Irritation Intracutaneous reactivity.
• Sensitization: Complies with ISO 10993-10: Delayed-Type Hypersensitivity (Sensitization) Buehler Test.

Frictional Properties:

• Tested per ASTM D1894, Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting under wet and dry conditions. (No specific numerical acceptance criteria provided in the document, only that a comparison was performed to a plain vinyl glove.)

User Study (Ease of Donning):

• Evaluated the amount of time it took to don the glove.
• Evaluated the amount of glove tears that occurred during donning. (No specific numerical acceptance criteria provided, comparison made to three other vinyl gloves coated with polyurethane.)

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

• Non-Clinical Testing (Physical Properties, Freedom from Holes, Residual Powder, Dimensions): The sample sizes are inherent to the ASTM D5250-06 and ASTM D5151-06 standards. The document doesn't explicitly state the exact number of gloves tested but indicates compliance with these standards, which define the sampling plans. The data provenance is not specified, but typically this testing is done by the manufacturer or a contract lab.
• Biocompatibility Testing: The sample sizes are inherent to the ISO 10993 standards for biological evaluation. The document doesn't explicitly state the exact number of animals or substances used, but indicates compliance with these standards.
• User Study: 170 subjects. The provenance (e.g., country of origin, retrospective/prospective) is not specified, but it's a prospective user study.

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

• No "experts" in the context of clinical interpretation (e.g., radiologists) were used to establish ground truth for this device, as it is a patient examination glove.
• The "ground truth" for the non-clinical tests is based on adherence to recognized international standards (ASTM, ISO). The experts involved would be the laboratory technicians and quality assurance personnel conducting and verifying these tests, but their specific qualifications are not detailed in the document.

4. Adjudication Method for the Test Set:

• Not applicable in the typical sense of clinical image review. For non-clinical tests, compliance is determined by meeting the specified criteria of the relevant ASTM and ISO 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 device is an examination glove, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device is an examination glove, not an algorithm.

7. The type of ground truth used:

• Physical Properties, Dimensions, Freedom from Holes, Residual Powder: Ground truth is defined by the specifications and test methods outlined in the ASTM D5250-06 and ASTM D5151-06 standards.
• Biocompatibility: Ground truth is established by the test methods and acceptance criteria defined in ISO 10993-10.
• Frictional Properties: Ground truth is established by the ASTM D1894 standard. A comparison was made against a "plain vinyl glove."
• User Study (Ease of Donning): Ground truth is based on quantitative measurements (time, tear count) observed during the study, compared to "three other vinyl gloves coated with polyurethane."

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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