(84 days)
This surgical glove is a device made of a neoprene – polyisoprene synthetic material intended to be worn by operating room personnel to protect a surgical wound from contamination.
NUZONE X2 ,powderfree surgical glove meets the requirements for surgical gloves described by the American Standard for Testing and Material ASTM D 3577 - 01a2.
Here's an analysis of the provided text regarding the NUZONE X2 Surgical Glove, focusing on the acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ASTM D 3577 - 01a2 & ASTM D512 for Physical Properties, ASTM F 719-81 & ASTM F 720-81 (86) for Biocompatibility) | Reported Device Performance |
|---|---|
| Physical Properties: Meets requirements for surgical gloves as described by ASTM D 3577-01a2 and other relevant ASTM standards (e.g., ASTM D512). | The product meets the requirements for surgical gloves per ASTM D 3577 – 01a² and ASTM D512. |
| Biocompatibility: Absence of Primary Skin Irritation (ASTM F 719-81). | Primary Skin Irritation test indicates no irritation. |
| Biocompatibility: Absence of Dermal Sensitization (ASTM F 720-81 (86)). | Dermal Sensitization Test indicates no sensitization. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for the physical property tests or the biocompatibility tests. It only indicates that "Test conducted per ASTM D 3577 – 01a², ASTM D512" and similar for biocompatibility. These ASTM standards typically outline the required sample sizes for such tests.
The data provenance is not specified beyond the fact that the tests were conducted. It's likely these were laboratory tests conducted by the manufacturer or a contracted testing facility, but the country of origin of the raw data/samples is not mentioned. These would be considered prospective tests performed specifically to support the 510(k) 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 the chemical and physical property testing of a medical glove. The "ground truth" for these tests is established by adherence to standardized testing methods (ASTM standards) and objective measurements. There is no mention of experts establishing a subjective "ground truth" for the test set in the context of this device.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., image analysis by multiple readers). The tests described for this device are objective measurements against established 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
Not applicable. This is a surgical glove, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI performance evaluation was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the objective performance standards defined by the relevant ASTM (American Society for Testing and Materials) standards. These standards specify acceptable ranges or thresholds for physical properties (e.g., tensile strength, elongation, barrier integrity) and the absence of certain biological reactions (irritation, sensitization). The device's performance is directly compared to these objective, scientific benchmarks.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The raw materials used for manufacturing would be subject to quality control, but this is a different concept than a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).