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A powder-free 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. In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) 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 nitrile with a blue colorant. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.

Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. The subject device was tested according to ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy agents.

This document is a 510(k) premarket notification for Medline Powder-Free Blue Nitrile Exam Gloves, Extended Cuff, which have been tested for use with chemotherapy drugs. It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly refers to acceptance criteria by stating "Complies with ASTM D6319-10" or by providing specific thresholds. The "reported device performance" is implicitly shown by the claim of compliance or the listed breakthrough times.

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

The document does not explicitly state the sample sizes used for each physical, biocompatibility, or permeation test. It only refers to compliance with specific ASTM and ISO standards (e.g., ASTM D6319, ASTM D6978, ISO 10993-10). These standards typically define the sampling plans required for testing.

• Data Provenance: The studies were non-clinical bench testing. The origin of the data is from Medline Industries, Inc. (the submitter). The document does not specify the country of origin for the actual testing or if it was retrospective or prospective, but it implies prospective testing conducted to support the 510(k) submission.

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

N/A. This is a non-clinical device (medical glove) and the testing involves objective measurement against performance standards (ASTM, ISO), not subjective interpretation by human experts to establish ground truth.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving reader agreement on subjective assessments. This device underwent bench testing against objective criteria.

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

No. An MRMC comparative effectiveness study is designed for evaluating diagnostic devices where human readers interpret medical images or data, often with and without AI assistance. This document describes the safety and performance testing of a physical medical device (gloves), not a diagnostic algorithm.

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

No. This concept is not applicable to a physical medical device like an examination glove. "Standalone performance" refers to the accuracy of an algorithm without human intervention, which is pertinent to AI/ML software as a medical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of these gloves is defined by the objective performance specifications outlined in recognized international standards:

• Physical properties: ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application). The "ground truth" is that a glove either meets the specified tensile strength, elongation, dimensions, AQL for pinholes, etc., or it does not.
• Biocompatibility: ISO 10993-10:2010/(R) 2014 (Biological Evaluation of Medical Devices – Part 10: Tests for irritation and skin sensitization). The "ground truth" is whether the device causes irritation or sensitization based on established biological test methods.
• Chemotherapy Drug Permeation: ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs). The "ground truth" is the measured breakthrough time of the specific chemotherapy drugs, as determined by the standardized test method.

8. The Sample Size for the Training Set

N/A. The concept of a "training set" applies to machine learning algorithms. This document describes the testing of a physical medical device, not an AI/ML algorithm.

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

N/A. As there is no training set for a physical product like a glove, this question is not applicable.

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