(71 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.
Powder-Free Sterile Synthetic Surgical gloves are formulated using Synthetic Rubber Latex. These are offered powder-free and sterile.
The provided document describes the safety and effectiveness of "Esteem Sterile Polyisoprene Surgical gloves," which are powder-free, sterile, synthetic surgical gloves. The study summarized in the document is a series of tests to demonstrate substantial equivalence to a predicate device, "Duraprene Powder-Free Sterile Synthetic Surgical Gloves." This is a premarket notification (510(k)) submission to the FDA.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Intracutaneous Reactivity | No irritation shown by predicate device | Gloves show no irritation. |
| Guinea Pig Maximization | No potential for sensitization shown by predicate device | Gloves do not display any potential for sensitization. |
| Ultimate Elongation & Tensile Strength | Meet requirements per ASTM D3577-00 for rubber surgical gloves | Gloves exceed requirements for rubber surgical gloves per ASTM D3577-00. |
| Barrier Defects (AQL) | Meet requirements per 21 CFR §800.20 and ASTM D3577-00, AQL = 1.5 | Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-00, AQL = 1.5. |
| Powder Level | Meet "Powder Free" designation, i.e., below 2 mg of residual powder per glove, using ASTM Standard D6124-97 | Results generated values below 2 mg of residual powder per glove. |
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 sample sizes used for any of the tests. It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) submission for a medical device (surgical gloves), these tests would typically be laboratory-based and conducted prospectively to evaluate the physical and biological properties 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 is not a diagnostic device or a device where "ground truth" is established by human expert interpretation in the way it is for imaging or clinical decision support AI. The "ground truth" for surgical gloves is defined by recognized industry standards (ASTM, CFR) and biological safety assessments. Therefore, the concept of "experts establishing ground truth for the test set" with specific qualifications (like a radiologist) is not applicable here. The tests themselves are the "truth" against established scientific and regulatory benchmarks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation or clinical endpoints where there might be disagreement. This is not relevant for the objective laboratory and biological tests conducted for surgical gloves. These tests yield quantitative results that are then compared against predefined criteria.
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
An MRMC comparative effectiveness study is not applicable as this is a device (surgical glove), not an AI algorithm for interpretation or diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical product (surgical glove), not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by:
- Industry Standards: ASTM D3577-00, ASTM Standard D6124-97
- Regulatory Requirements: 21 CFR §800.20
- Biological Safety Assessments: Intracutaneous Reactivity and Guinea Pig Maximization tests, which rely on established methods for assessing biocompatibility.
8. The sample size for the training set
This question is not applicable as this is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as this is a physical device, not an AI model that requires a training set.
§ 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).