Search Results

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

Textured Powder-Free Latex Examination Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram

This FDA letter is a premarket notification (510(k)) clearance for medical gloves. It does not contain the detailed information about acceptance criteria or specific studies proving device performance that you've requested.

The letter approves the device, indicating that it has been found "substantially equivalent" to legally marketed predicate devices, meaning it meets the same safety and effectiveness standards. However, it does not describe the specific testing or the acceptance criteria used to reach that determination.

Therefore, I cannot provide the information you asked for based on this document. This kind of detail would typically be found in the actual 510(k) submission, not in the clearance letter itself.

Ask a specific question about this device