Search Results

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Glove, White (non-colored) or Blue (Colored)

The provided document is an FDA 510(k) clearance letter for a "Powder Free Nitrile Examination Glove." This type of document does not contain the information requested in the prompt regarding acceptance criteria and a study proving a device meets them.

The 510(k) process is primarily about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily providing detailed performance studies with acceptance criteria in the manner described for more complex diagnostic or AI-based devices.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on:

• Confirming the device's substantial equivalence.
• Stating its regulation number, name, and product code.
• Listing general controls and other FDA regulations applicable to the device.
• Specifying the "Indications for Use" for the glove.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, or test sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set details.
9. Ground truth establishment for training sets.

Ask a specific question about this device