Search Results

The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Powder Free Examination Gloves (Blue); Nitrile Powder Free Examination Gloves (Pink)

This document is a 510(k) premarket notification letter from the FDA regarding "Nitrile Powder Free Examination Gloves (Blue)" and "Nitrile Powder Free Examination Gloves (Pink)". It confirms that the devices are substantially equivalent to legally marketed predicate devices.

This document does not contain information about the acceptance criteria or a study proving the device meets those criteria, as requested in the prompt.

The provided text is a regulatory clearance letter, not a scientific study report. It states that the device is substantially equivalent for the indications for use, which are for medical and dental purposes to prevent contamination between patient and examiner. However, it does not detail any specific performance metrics, test methods, or study results.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device

The nitrile examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Powder Free Examination Gloves (Blue)

I am sorry, but the provided text only contains a 510(k) clearance letter from the FDA for Nitrile Powder Free Examination Gloves. This letter confirms that the device is substantially equivalent to a legally marketed predicate device.

The document does not contain any information about the acceptance criteria or a study proving the device meets those criteria, nor does it include details about a specific performance study with the requested information (sample sizes, ground truth establishment, expert qualifications, etc.).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as that information is not present in the provided text.

Ask a specific question about this device