Search Results

A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.

Powderfree Latex Examination Gloves (Protein Label Claim) C 50mcg of

This document is an FDA 510(k) clearance letter for "Powderfree Latex Examination Gloves (Protein Trade Name: Label Claim)." It is not a study that evaluates a medical device against acceptance criteria using performance data. Therefore, I cannot extract the requested information.

The letter simply states that the FDA has reviewed the manufacturer's notification and determined that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. It does not contain any details about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

Ask a specific question about this device

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

Powderfree Latex Examination Gloves (Protein Label Claim) 50 MICROGRAMS OR LESS

I'm sorry, but without further context, I cannot extract the specific acceptance criteria and detailed study information you're looking for. The provided text is a 510(k) clearance letter from the FDA, which confirms the substantial equivalence of Powderfree Latex Examination Gloves to a predicate device.

This document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets.
• Information on ground truth establishment, expert qualifications, or adjudication methods.
• Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The letter focuses on the regulatory clearance process for a medical device (gloves), not on a study proving a device meets specific technical performance criteria in the way you've outlined.

To provide the information you requested, I would need a different document, such as a clinical study report, a performance evaluation report, or a detailed technical specification document for a device that uses algorithms or requires complex performance analysis.

Ask a specific question about this device