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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:

1. 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.
2. 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.
3. Number of experts and their qualifications for ground truth: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study or human reader improvement: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. 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.

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