(64 days)
These powder-free sterile 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 the environments within hospitals and other healthcare facilities.
Gloves are formulated using neoprene. They are coated with nitrile coating and are offered powder-free and sterile.
Here's a breakdown of the acceptance criteria and the study information for the Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating, based on the provided text:
Based on the provided 510(k) summary, this document describes a device for general medical use (surgical gloves), not an AI/ML-based device. Therefore, many of the requested fields related to AI/ML studies, such as sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, and how ground truth was established, are not applicable to this submission. The "study" here refers to standard performance testing for medical gloves.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating
| Test / Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization (Sensitization Potential) | Gloves do not display any potential for sensitization. |
| Dimensions (meets requirements of ASTM D3577) | Gloves meet requirements of ASTM D3577. |
| Physical Characteristics (Tensile Strength, Elongation, etc.) (meets requirements for rubber surgical gloves per ASTM D3577) | Gloves meet requirements for rubber surgical gloves per ASTM D3577. |
| Freedom from Holes (meets requirements of 21 CFR 800.20 and ASTM D3577) | Gloves meet requirements of 21 CFR 800.20 and ASTM D3577. |
| Powder Residual (meets powder level requirements for "Powder-Free" designation per ASTM D3577, tested using ASTM standard D6124 - below 2mg/glove) | Results generated values below 2mg of residual powder per glove, meeting powder level requirements for "Powder-Free" designation per ASTM D3577 tested using ASTM standard D6124, Standard test method for residual powder on medical Doves. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for each test. Testing for medical gloves typically involves sampling a certain number of gloves from production lots according to relevant ASTM standards (e.g., ASTM D3577 for physical properties and freedom from holes, ASTM D6124 for powder residual).
- Data Provenance: The manufacturing location is listed as "7/111 Moo 4, Highway 331 Mabyangporn Pluakdaeng, Rayong, 21140, Thailand." The data is likely prospective testing performed on manufactured gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not an AI/ML device where expert ground truth is established in the same manner. The "ground truth" for glove performance is determined by adherence to established governmental regulations (21 CFR 800.20) and industry standards (ASTM D3577, ASTM D6124), often through instrumental measurements and standardized methods rather than expert consensus on complex interpretations.
4. Adjudication method for the test set
- Not Applicable. No adjudication method, such as 2+1 or 3+1, is mentioned or would be relevant for these types of physical and chemical tests on surgical gloves. Performance is assessed against quantitative thresholds defined by 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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used
- The ground truth for this device is based on established regulatory requirements (21 CFR 800.20) and recognized industry performance standards (ASTM D3577, ASTM D6124). These standards define the acceptable range or threshold for specific physical and chemical properties of the gloves.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML 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).