(78 days)
These gloves are intended for use 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. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Coated Sterile Latex Powder-free Surgical gloves are formulated using natural rubber latex and are coated with a nitrile coating. These are offered powder-free and sterile.
This document describes the safety and effectiveness of "Coated Sterile Latex Powder-Free Surgical Gloves." It does not pertain to an AI device or a study involving human readers or algorithms. Therefore, much of the requested information about AI model performance, expert ground truth, adjudication methods, and sample sizes for training/test sets is not applicable.
However, I can extract information related to the acceptance criteria and the summary of testing for this medical device.
Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit from "meets or exceeds requirements" or regulations) | Reported Device Performance |
|---|---|---|
| Systemic Toxicity | Gloves should not elicit any toxic reactions to acute application. | Gloves do not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | Gloves should show no reactivity. | Gloves show no reactivity. |
| Guinea Pig Maximization | Gloves should not display any potential for irritation. | Gloves do not display any potential for irritation. |
| Ultimate Elongation & Tensile Strength | Meet or exceed requirements for rubber surgical gloves per ASTM D3577-99. | Gloves meet or exceed requirements for rubber surgical gloves per ASTM D3577-99. |
| Barrier Defects | Exceed requirements per 21 CFR §800.20, AQL = 2.5. | Gloves exceed requirements per 21 CFR §800.20, AQL = 2.5. |
| Powder Level | Meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-97 (values below 4 mg of residual powder per glove). | Results generated values below 4 mg of residual powder per glove. |
Information Not Applicable or Not Provided for this Device:
- Sample size used for the test set and the data provenance: Not specified, as this is a physical medical device, not an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device performance is measured through physical and chemical tests, not expert consensus on images/data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For physical medical devices, "ground truth" is established through standardized laboratory tests and regulatory requirements (e.g., ASTM standards, CFR regulations).
- The sample size for the training set: Not applicable. This is not an AI model.
- How the ground truth for the training set was established: Not applicable. This is not an AI model.
§ 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).