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This powder-free surgeon's glove is a disposable device made of synthetic 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 sterile. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is synthetic rubber latex. This sterile polyisoprene powder-free surgical glove is manufactured using exact same material used in the currently cleared device, Esteem Blue glove (K042574) that has been legally marketed by Cardinal Health for many years. 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. It is offered powder-free and sterile.

This document describes the regulatory submission for Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera® Coating (hereinafter referred to as "the device"). The submission is a 510(k) premarket notification, indicating that the device is a modification of a currently marketed device (Esteem® Blue Sterile Polyisoprene Powder-Free Surgical Gloves with Neu-Thera Coating, cleared under 510(k) K042574).

The document is a summary of safety and effectiveness, focusing heavily on comparative performance data with a predicate device rather than a comprehensive new device study. Therefore, many of the typical elements of an AI/ML device acceptance criteria and study are not applicable in this context.

Here's an analysis based on the provided text, addressing the points you requested:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (surgical gloves), the "acceptance criteria" are based on meeting established industry standards (ASTM and ISO) and regulatory requirements (21 CFR). The "performance" is demonstrated by showing that the new device meets these standards and is comparable to the predicate device.

Comparative Performance Summary (New Device vs. Predicate Device)

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for Freedom from Holes). However, it implies that standard methodologies prescribed by ASTM and ISO were followed for each test, which would inherently include appropriate sample size requirements for those standards.

• Data Provenance: The tests are non-clinical (laboratory/bench testing) performed on the manufactured gloves. There is no information regarding the country of origin of the data beyond the applicant's location (McGaw Park, IL, USA). The data is generated prospectively as part of the manufacturing and quality control process for the device submission.

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

This is not applicable to this type of device. The "ground truth" for surgical gloves is established by objective engineering and material science standards (e.g., tensile strength, tear resistance, barrier integrity, biocompatibility as per ISO/ASTM standards), not by human expert opinion or interpretation like in an AI/ML diagnostic device.

4. Adjudication Method for the Test Set

This is not applicable. As the tests are objective, physical, and chemical measurements against defined standards, there is no need for expert adjudication.

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 is not applicable. This submission is for a physical medical device (surgical gloves), not an AI/ML diagnostic or assistive device for human readers. There are no "human readers" in the context of this device's function.

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

This is not applicable. There is no algorithm or AI component in this device. Performance is assessed through physical, chemical, and biological testing of the material and finished product.

7. The Type of Ground Truth Used

The "ground truth" (or basis for compliance) for this device is based on:

• Industry Standards: Compliance with established ASTM (American Society for Testing and Materials) standards (e.g., D3577 for rubber surgical gloves, D6124 for residual powder) and ISO (International Organization for Standardization) standards (e.g., 10993-1, 10993-10 for biocompatibility).
• Regulatory Requirements: Meeting specifications outlined in 21 CFR (e.g., 800.20 for Freedom from Holes).

These standards define the acceptable physical properties, chemical composition, and biological safety for surgical gloves.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable. There is no "training set" or need for establishing a ground truth for it.

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