Search Results

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Patient Vinyl Examination Gloves, Powderfree, Non-Sterile

This request cannot be fulfilled as the provided text is a 510(k) clearance letter for patient examination gloves. This type of document declares substantial equivalence to a predicate device and does not contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the AI/ML device context described in the request. The letter is a regulatory compliance document for a physical medical device (gloves), not an AI/ML algorithm.

Ask a specific question about this device

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between paties: and examiner (21CFR 880.6250)

Patient Vinyl Examination Gloves, Powdered

The provided document is a 510(k) premarket notification letter from the FDA for a device described as "Patient Vinyl Examination Gloves, Powdered." This document does not contain information about acceptance criteria, device performance studies, or details relevant to AI/ML device testing. It is a regulatory clearance document for a traditional medical device (gloves), indicating that it has been found substantially equivalent to a predicate device.

Therefore, I cannot provide the requested information from this document. The questions about acceptance criteria, sample size, ground truth, expert qualifications, and AI study details are not applicable to the content of this regulatory letter.

Ask a specific question about this device