(57 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); 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.
§ 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.