(42 days)
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.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.