(29 days)
A powder-free surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Elastyfree™ Synthetic Powder-Free Surgical Glove
This document is an FDA 510(k) clearance letter for the "Elastyfree™ Synthetic Powder-Free Surgical Glove." It does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria in the manner typically described for AI/ML or diagnostic devices.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or it has different technological characteristics but is as safe and effective as a legally marketed device.
Therefore, I cannot provide the requested information for an AI/ML or diagnostic device based on this document. The "Elastyfree™ Synthetic Powder-Free Surgical Glove" is a physical medical device (a surgical glove), and its clearance is based on demonstrating substantial equivalence, not on performance metrics against predefined acceptance criteria from a specific study as would be detailed for a diagnostic algorithm.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance: This type of data is not included in an FDA 510(k) clearance letter for a simple physical device like a glove.
- Sample size for the test set and data provenance: Not applicable here as there isn't a "test set" in the context of an algorithm or diagnostic device.
- Number of experts and their qualifications for ground truth: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study or human reader improvement: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
The "Indications for Use Statement" on page 3 simply describes what the glove is and its intended purpose as a barrier. The clearance emphasizes that the device meets general controls provisions and is substantially equivalent to existing devices.
§ 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).