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

The Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) are single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, light blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.

This document is a 510(k) summary for the Medline Powder-Free Light Blue Nitrile Exam Gloves, which have been tested for use with chemotherapy drugs. It is a report from Medline Industries, Inc. to the U.S. Food & Drug Administration (FDA) dated September 18, 2020. The purpose of this summary is to demonstrate substantial equivalence to a legally marketed predicate device (K172525).

Here's a breakdown of the requested information based on the provided text:

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

The document provides performance data for resistance to permeation by chemotherapy drugs, evaluated per ASTM D6978-05 (Reapproved 2019). The "acceptance criteria" can be inferred from the "≥ 240 Minutes" value for most drugs, indicating that a barrier of at least 240 minutes is considered acceptable for practical use, though specific quantitative acceptance criteria are not explicitly stated for all tests. For Carmustine and Thio-Tepa, specific (lower) breakthrough times are reported, along with cautions/warnings.

Notes on Biocompatibility: The "Cytotoxic / Non-Toxic" entry under the proposed device's biocompatibility in the table (page 5) is contradictory. Under the "Summary of Non-Clinical Testing" (page 8), it explicitly states that ISO 10993-05: Cytotoxicity was performed. However, the result in the comparison table is listed as "Cytotoxic / Non-Toxic." Assuming the test was conducted and the device is intended for medical use, it should generally be "Non-Toxic." For this response, I've noted the apparent contradiction.

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

The document does not specify the sample sizes for the various tests (e.g., number of gloves tested for chemotherapy permeation, physical properties, or biocompatibility). It only states that the tests were performed "per ASTM D6978-05 (Reapproved 2019)" and other standards.

The provenance (country of origin, retrospective/prospective) of the data is not mentioned. It is implied to be prospective testing conducted for the purpose of this 510(k) submission.

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

This information is not applicable to this type of device and study. The "ground truth" here is established through standardized laboratory testing (ASTM standards) of physical and chemical properties, not through expert human interpretation of medical images or clinical observations. Therefore, there are no medical experts establishing ground truth in the context of this submission. The "experts" would be the accredited laboratories and technicians conducting the ASTM tests.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where there is subjective interpretation of data (e.g., medical images) by multiple human readers, and a consensus needs to be reached. For standardized laboratory tests of physical properties, the results are quantitative and objective, and thus adjudication is not necessary.

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

This information is not applicable. This submission is for medical gloves, which are a physical device, and does not involve AI or human readers for diagnostic or interpretive tasks.

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

This information is not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used

The ground truth for the device's performance is established by standardized laboratory test methods and their defined parameters. Specifically:

• Chemotherapy Permeation: ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The "ground truth" is the breakthrough time measured according to this standard.
• Physical Properties: ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application. The "ground truth" is the measured tensile strength, elongation, dimensions, etc., according to this standard.
• Freedom from Holes: ASTM D5151-06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical Gloves.
• Residual Powder: ASTM D6124-06 (Reapproved 2011) Standard Test Method for Residual Powder on Medical Gloves.
• Biocompatibility: ISO 10993-10 (Primary Skin Irritation, Dermal Sensitization), and ISO 10993-05 (Cytotoxicity). The "ground truth" is the biological response observed according to these standards.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of laboratory testing of a physical medical device. This term typically refers to machine learning algorithms.

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

This information is not applicable for the same reason as point 8.

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