Search Results

A pation cxamination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Latex Patient Examination Gloves (Powder-Trade Name: Free) with Protein Content Labeling Claim (50 micrograms or less)

Please provide the "Input" in the format specified by your request. The current input is malformed, with page numbers and descriptive text mixed with the content. I need a clear, contiguous block of text for analysis.

Once formatted correctly, I will be able to extract the requested information about acceptance criteria and the study proving device conformance.

Ask a specific question about this device

Patient examination gloves are "disposable medical devices intended for medical purposes that are worn on the examiner's hand to help prevent contamination between patient and examiner".

Latex Patient examination gloves, Powder Free

This document is a 510(k) clearance letter from the FDA for "Powder-Free, Latex Patient Examination Gloves." It does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria.

The letter simply states that the FDA has reviewed the submission and determined the device is "substantially equivalent" to legally marketed predicate devices. It does not provide:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment.
• Information on expert adjudication, MRMC studies, or standalone algorithm performance.
• Any specifics on the studies conducted to demonstrate the device's performance.

The letter is a regulatory approval, not a scientific study report. Therefore, I cannot fulfill your request with the provided input.

Ask a specific question about this device