Search Results

A single use disposable device intended for medical purposes that is worn on the hands of examiners to prevent contamination between the examiner and the patient.

Non-Sterile Powder Free Nitrile Examination Gloves

The provided text
describes the FDA's administrative change and substantial equivalence (SE)
determination for "Non-Sterile Powder Free Nitrile Examination Gloves" (K223221).
However, it does not contain any information regarding acceptance criteria,
device performance study results, sample sizes, expert qualifications, or ground
truth establishment.

This document is an FDA 510(k) clearance letter, which
primarily addresses the regulatory classification and marketing authorization of a
medical device. It confirms that the device is substantially equivalent to
legally marketed predicates and can be marketed subject to general controls. It does
not include the detailed technical performance study data typically found in a
submission document or a summary of safety and effectiveness.

Therefore, I cannot provide the requested information
(Table of acceptance criteria, sample sizes, expert details, adjudication,
MRMC study, standalone performance, ground truth types, or training set
details) based on the provided text.

Ask a specific question about this device