(174 days)
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.
Esteem Sterile Polyisoprene Surgical Gloves with Coating are formulated using Synthetic Rubber Latex. These are offered powder-free and sterile.
This document pertains to the 510(k) summary of safety and effectiveness for the Esteem Sterile Polyisoprene Surgical Gloves with Coating. The information provided focuses on the physical and biological characteristics of the gloves, and therefore, many of the requested criteria regarding AI/algorithm performance are not applicable.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Primary Skin Irritation | Gloves are non-irritating. |
| Guinea Pig Maximization (Sensitization) | Gloves do not display any potential for sensitization. |
| Ultimate Elongation & Tensile Strength | Gloves exceed requirements for rubber surgical gloves per ASTM D3577-01. |
| Barrier Defects | Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-01, AQL = 1.5. |
| Residual Powder Level | Gloves meet powder level requirements ("Powder Free" designation) using ASTM Standard D6124-00; results below 2 mg of residual powder per glove. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test (e.g., number of gloves tested for barrier defects, number of animals for skin irritation/sensitization). The provenance of the data (country of origin, retrospective/prospective) is also not explicitly stated, but it can be inferred that these are standard laboratory tests conducted by the manufacturer, Cardinal Health, likely in the US where the 510(k) application was made.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the evaluation of surgical gloves. The "ground truth" for these tests is based on established scientific and regulatory standards (e.g., ASTM standards, CFR regulations) and laboratory measurements, not expert consensus on interpretations.
4. Adjudication method for the test set
Not applicable. The tests involve objective measurements against predefined standards. There is no mention of adjudication in the context of interpretation or consensus building.
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 device is a physical medical device (surgical gloves), not an AI or imaging-based diagnostic tool. Therefore, MRMC studies and AI-related performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance of these surgical gloves is based on:
- Established Industry Standards: ASTM International (e.g., D3577-01 for rubber surgical gloves, D6124-00 for residual powder).
- Regulatory Requirements: 21 CFR §800.20 related to barrier defects.
- Biological Testing Standards: Methods for evaluating skin irritation and sensitization (e.g., Guinea Pig Maximization Test).
These are objective, measurable criteria, not subjective expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.
8. The sample size for the training set
Not applicable. There is no machine learning or AI component that would require a training set.
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).