(147 days)
The Nitrile examination gloves is a non - sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Powder Free Examination Gloves (White)
The provided document is a 510(k) premarket notification approval letter for Nitrile Powder Free Examination Gloves. It does not contain information about the acceptance criteria and study detailed for an AI/ML device. Therefore, I cannot extract the requested information to fill in the table and answer the questions.
The document discusses:
- The approval of the device (Nitrile Powder Free Examination Gloves) based on substantial equivalence to legally marketed predicate devices.
- The regulatory classification and product code for the device.
- General controls provisions of the Act that apply to the device.
- The indication for use of the gloves.
There is no mention of an algorithm, AI, machine learning, or any performance study parameters typically associated with such devices, or ground truth establishment.
§ 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.