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These powder-free sterile light brown colored surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Please note that the following drug has extremely low permeation time of less than 30 minutes: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.20 minute.

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using neoprene synthetic polymer and are coated with nitrile coating. The gloves are manufactured using exact same material used in the currently cleared device, Duraprene SMT gloves, that have been legally marketed by Cardinal Health under K102500. The gloves are manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. They are light brown in color and are offered powder-free and sterile.

The acceptance criteria and device performance are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., number of gloves tested for permeation, number of animals for biocompatibility). The testing was conducted according to established international and national standards (ISO 10993-10, ASTM D3577, ASTM D6124, ASTM D6978, 21 CFR 800.20). These standards typically specify the required sample sizes for such tests to ensure statistical validity. The data provenance is not specified in terms of country of origin, but it is implied to be from testing labs adhering to these standards, likely in association with Cardinal Health for regulatory submission in the USA. The data would be prospective, as it was generated specifically for this 510(k) submission.

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

This device is a medical glove, a physical product, and the "ground truth" for its performance is established through objective laboratory testing against material and safety standards, not through expert consensus on interpretation of data like in an imaging study. Therefore, the concept of "experts used to establish ground truth" in the way it applies to diagnostic AI is not relevant here. The ground truth is defined by the technical specifications and performance limits set by the referenced ASTM and ISO standards and FDA regulations. The "experts" in this context would be the qualified laboratory personnel conducting the tests and the regulatory bodies defining these standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, performance is measured against objective standards, not through subjective human interpretation requiring adjudication.

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 typically used for diagnostic devices where human readers interpret images or other data, and the AI's impact on their performance is being evaluated. This document pertains to a medical glove, where performance is assessed through physical and chemical testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance assessment was done. The device performance (e.g., physical properties, biocompatibility, chemotherapy drug permeation) was evaluated independently through laboratory testing, without a "human-in-the-loop" component in the sense of a diagnostic interpretation task. The "algorithm" here is the glove itself, and its performance is measured directly against predefined criteria.

7. The Type of Ground Truth Used

The ground truth used is based on objective measurements and predefined standards (ASTM D3577, ASTM D6978, ISO 10993-10, 21 CFR 800.20). For example:

• Physical properties: Measured values (e.g., dimensions, tensile strength) compared against specified limits in ASTM D3577.
• Freedom from holes: Determined by a water leak test (ASTM D5151) and assessed against AQL (Acceptable Quality Level) requirements as per 21 CFR 800.20 and ASTM D3577.
• Powder residual: Quantitative measurement of powder per glove (ASTM D6124) compared against the < 2.0 mg/glove requirement for "powder-free."
• Chemotherapy drug permeation: Measured breakthrough detection time of specific chemotherapy drugs compared against a standard detection limit (0.01 µg/cm²/minute) over a specified testing period (up to 240 minutes) detailed in ASTM D6978 for each drug.
• Biocompatibility: Results from established biological evaluation tests (e.g., primary skin irritation, guinea pig maximization) against criteria in ISO 10993-10.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not a software algorithm that requires a "training set" in the context of machine learning.

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

Not applicable. As above, this is a physical medical device, not an AI/ML algorithm requiring a training set.

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