Search Results

A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E

This document is a 510(k) premarket notification letter from the FDA regarding "Disposable Powder Free Vinyl Examination Gloves With Vitamin E". It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not describe acceptance criteria for a study, nor does it present the results of a study to prove a device meets acceptance criteria. The structure of the request, with questions about sample size, expert ground truth, adjudication methods, and AI performance, is typically relevant for studies evaluating the performance of AI/ML-driven medical devices or diagnostic tests.

This letter solely concerns the regulatory clearance of a physical medical device (examination gloves), not an AI/ML algorithm or a diagnostic test with performance metrics of the type requested. Therefore, none of the specific questions can be answered from the provided text.

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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN E

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is a letter from the FDA regarding a 510(k) premarket notification for "Disposable Powder Free Vinyl Examination Gloves, with Vitamin E." It confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory responsibilities.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.

Ask a specific question about this device