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This powder-free surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a disposable device intended for over the counter use and is provided powder-free sterile. It is made with natural rubber latex. The glove is coated with nitrile coating. The glove is manufactured using exact same material used in the currently cleared device, Protegrity Blue glove (K053272). The glove is coated with emollient coating (containing Glycerol. Gluconolactone, D-Sorbitol and Provitamin-B). The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down.

The provided text describes the acceptance criteria and performance of Cardinal Health Protexis™ Latex Powder-Free Blue Surgical Gloves with Neu-Thera® Coating. It is a 510(k) submission, meaning the device is seeking substantial equivalence to a legally marketed predicate device, not necessarily proving revolutionary new efficacy.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of typical AI/software device studies. Instead, it refers to performance testing of the physical glove. The sample sizes for each specific test (e.g., biocompatibility, physical properties, freedom from holes) are not explicitly stated in this summary. It only indicates that tests were performed "in accordance with" the specified ASTM and ISO standards, which would imply a defined sample size for each test within those standards.

The data provenance is from non-clinical tests performed by Cardinal Health (the applicant). There is no mention of country of origin for the data, but the company is based in McGaw Park, IL, USA. The studies are prospective in the sense that they are conducted to demonstrate the properties of the manufactured glove for regulatory submission.

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

This information is not applicable to this type of device and study. The "ground truth" for glove performance characteristics (dimensions, hole-free, protein content, etc.) is established by adherence to standardized measurement protocols defined by ASTM and ISO, rather than expert consensus. For biocompatibility, the "ground truth" on irritation and sensitization is determined by the results of standardized animal tests as per ISO 10993-10. There are no human experts involved in establishing a "ground truth" in the way one would for a diagnostic AI study.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are typically used in clinical studies or expert-based evaluation of medical images or diagnoses, not for the physical and biological testing of a surgical glove as described here. The results are objective measurements against defined 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

No, an MRMC comparative effectiveness study was not done. This device is a surgical glove, not an AI or diagnostic tool that assists human "readers" or practitioners in interpreting information.

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

No, a standalone performance study in the context of an algorithm or AI is not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on standardized test methods and predetermined criteria outlined in the referenced ASTM and ISO standards, and FDA regulations (21 CFR 800.20):

• Physical Characteristics: Measured values (e.g., dimensions, force at break, elongation, powder residual, protein content) are compared against the numerical thresholds and ranges specified in ASTM D3577, ASTM D6124, ASTM D5712, and 21 CFR 800.20.
• Biocompatibility: The observed biological responses (skin irritation, sensitization potential) in animal models are evaluated against the criteria for "non-irritating" and "no potential for sensitization" as established by ISO 10993-10.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical product (surgical glove) and does not involve AI or machine learning, therefore, there is no "training set." The glove's manufacturing process is established and validated, not "trained."

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

This is not applicable as there is no training set for this type of device.

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