Search Results

A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or contamination between patient and finger to prevent examiner.

Powdered Green Latex Examination Gloves

The provided document is an FDA 510(k) clearance letter for "Powdered Green Latex Examination Gloves." This document does not contain any information regarding acceptance criteria, device performance studies, or details about AI-based device evaluations.

The letter is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses general controls, regulations, and contact information for the manufacturer.

Therefore, I cannot answer your request based on the provided text. There is no information in the document about:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, or adjudication methods for a test set.
3. Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
4. Type of ground truth or training set details.

Ask a specific question about this device

A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Green Latex Examination Gloves

This document is a 510(k) clearance letter from the FDA for "Powdered Green Latex Examination Gloves." This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria.

The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving specific performance metrics against pre-defined acceptance criteria through a detailed study like one would find for a novel or high-risk device.

Therefore, I cannot provide the requested information based on this document.

Ask a specific question about this device