Search Results

Ask a specific question about this device

A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Powder-Free Latex Examination Glove

This document is a 510(k) clearance letter from the FDA for a medical device: "HWA (and)Silktex Powder-Free Latex Examination Glove". It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. This type of information (device performance metrics, study design, ground truth establishment, sample sizes, etc.) is typically found in the accompanying 510(k) summary or detailed submission, not in the clearance letter itself.

Therefore, I cannot provide the requested information based solely on the text provided. The document confirms market clearance but does not detail the technical performance characteristics or the studies behind them.

Ask a specific question about this device