(48 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 Ortho Polyisoprene Powder-Free Surgical gloves are formulated using synthetic rubber latex. They are offered powder-free and sterile.
The provided text describes the performance testing for "Esteem Ortho Polyisoprene Powder-Free Surgical Gloves" to establish substantial equivalence to predicate devices, rather than a study proving a device meets acceptance criteria related to AI/ML performance.
Therefore, many of the requested categories are not applicable to this document. However, I can extract the relevant information from the performance testing section.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | Non-irritating (implied) | Gloves are non-irritating. |
| Guinea Pig Maximization (Sensitization) | No potential for sensitization (implied) | Gloves do not display any potential for sensitization. |
| Dimensions | Meet requirements of ASTM D3577 | Gloves meet requirements of ASTM D3577. |
| Ultimate Elongation & Tensile Strength | Meet requirements for rubber surgical gloves per ASTM D3577 | Gloves meet requirements for rubber surgical gloves per ASTM D3577. |
| Freedom from Holes | Meet requirements of 21 CFR 800.20 and ASTM D3577 | Gloves meet requirements of 21 CFR 800.20 and ASTM D3577. |
| Powder Residual | Meet powder level requirements for "Powder-Free" designation per ASTM D3577, tested using ASTM D6124 | Results generated values below 2mg of residual powder per glove. |
2. Sample size used for the test set and the data provenance: Not applicable. These are physical/material property tests on manufacturing batches, not a "test set" in the context of AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is established by standardized material testing procedures.
4. Adjudication method for the test set: Not applicable.
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: Standardized material testing methods (e.g., ASTM standards) define the "ground truth" for the physical properties of the gloves.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.
Summary of the Study:
The "study" in this context refers to a series of performance tests conducted on the Esteem Ortho Polyisoprene Powder-Free Surgical Gloves to demonstrate their safety and effectiveness and establish substantial equivalence to predicate devices. The tests focused on physical characteristics and biocompatibility.
- Acceptance Criteria and Performance: As detailed in the table above, the acceptance criteria for various physical and biological properties are primarily based on ASTM D3577 (Standard Specification for Rubber Surgical Gloves) and 21 CFR 800.20 (dealing with freedom from holes). For each test, the gloves were found to meet these specified requirements (e.g., non-irritating, non-sensitizing, meeting dimensional and strength requirements, freedom from holes, and low powder residual).
- Clinical Data: No clinical data was required for this submission. This indicates that the safety and effectiveness were sufficiently demonstrated through the non-clinical performance testing and substantial equivalence to already cleared devices.
In conclusion, the device does meet the acceptance criteria outlined in the 510(k) submission, as demonstrated by the performance testing results, which align with established industry standards and regulatory requirements for surgical gloves.
§ 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).