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A PATIENT EXAMINATION GLOVES 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.

ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN, YELLOW GOLD COLOR

This document is a 510(k) clearance letter from the FDA for a medical device: "Ennoble Disposable Powder Free Vinyl Synthetic Exam Gloves With Vitamin Complex, Nopal and Lanolin, Yellow Gold Color."

This type of document (510(k) clearance) does not contain the detailed information required to answer your specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.

A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing device specifications, materials, and performance standards to the predicate. The FDA letter confirms this substantial equivalence has been met, but it does not delve into the specific studies and data you're requesting that would typically be found in a clinical study report or a more detailed technical submission.

Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical study demonstrating device performance against specific acceptance criteria.

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