Search Results

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

Elastyren Powder-Free Patient Examination Gloves

The provided text is a 510(k) clearance letter from the FDA for "Elastyren Powder-Free Patient Examination Gloves." It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone algorithm performance).

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated uses. It refers to general controls provisions of the Act (e.g., annual registration, good manufacturing practice) but does not detail specific performance-based acceptance criteria or the studies used to demonstrate those specific criteria for the gloves themselves.

Therefore, I cannot extract the requested information from the provided document.

Ask a specific question about this device