(9 days)
These powder-free 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.
Esteem SMT Polyisoprene Powder-Free Surgical gloves are formulated using synthetic rubber latex. They are offered powder-free and sterile.
The Esteem SMT Polyisoprene Powder-Free Surgical Gloves were subject to several performance tests to demonstrate substantial equivalence. The acceptance criteria and reported device performance are summarized below:
1. Table of Acceptance Criteria and Reported Device Performance
| Test: | Acceptance Criteria: | Reported Device Performance: |
|---|---|---|
| Primary Skin Irritation | Gloves must be non-irritating. | Gloves are non-irritating. |
| Guinea Pig Maximization | Gloves must not display any potential for sensitization. | Gloves do not display any potential for sensitization. |
| Dimensions | Must meet requirements of ASTM D3577. | Gloves meet requirements of ASTM D3577. |
| Physical Characteristics | Must meet requirements for rubber surgical gloves per ASTM D3577. | Gloves meet requirements for rubber surgical gloves per ASTM D3577. |
| Freedom from Holes | Must meet requirements of 21 CFR 800.20 and ASTM D3577. | Gloves meet requirements of 21 CFR 800.20 and ASTM D3577. |
| Powder Residual | Must meet powder level requirements for "Powder-Free" designation per ASTM D3577, tested using ASTM standard D6124. | Results generated values below 2mg of residual powder per glove, meeting the "Powder-Free" designation. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each test. The tests were performed by Cardinal Healthcare 222 LTD. in Rayong, Thailand, which is the country of origin. The study appears to be prospective testing of the manufactured gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a medical glove, not an AI or imaging device that requires interpretation by medical experts. Therefore, the concept of "experts establishing ground truth for the test set" and their qualifications as typically understood in AI/imaging studies (e.g., radiologists) is not applicable. The ground truth for glove performance is established by standardized material and physiological testing methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as this is not an AI or imaging device requiring human adjudication of results from a diagnostic test. Performance is determined by established physical and biological testing 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 as this is a physical medical device (surgical gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable as this is a physical medical device. The "standalone" performance here refers to the glove's intrinsic properties as measured by the specified tests, without human intervention in the measurement of those properties (although humans would be performing the tests).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device is based on established industry standards and regulatory requirements for medical gloves. This includes:
- ASTM D3577: Standard Specification for Rubber Surgical Gloves.
- 21 CFR 800.20: Regulations regarding freedom from holes in surgeon's gloves.
- ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves.
- Biological safety standards: For skin irritation and sensitization (e.g., Primary Skin Irritation and Guinea Pig Maximization tests).
These standards define the objective criteria and methods against which the glove's performance is measured.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model, hence no "training set" in the context of AI.
9. How the ground truth for the training set was established
Not applicable for a physical 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).