(98 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.
FreeForm Blue Powder Free Nitrile Examination Gloves
This document is an FDA 510(k) clearance letter for "FreeForm Blue Powder Free Nitrile Examination Gloves." It does not contain information about a study proving the device meets acceptance criteria, an AI system, or performance metrics typically associated with medical device studies.
The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined it is as safe and effective as a device already on the market. This type of clearance does not typically involve the detailed performance studies or AI-specific information requested in your prompt.
Therefore, I cannot provide the requested information from this document.
§ 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.