(85 days)
A patient examination glove is a disposable device intended for medical purposes that is donned by doctors and healthcare workers as protection against possible infection/contamination when examining a patient.
Powderfree Colored and Flavored Nitrile Copolymer Patient Examination Gloves.
The provided document is a 510(k) premarket notification letter from the FDA regarding "Powderfree Colored and Flavored Nitrile Copolymer Patient Examination Gloves." This document is a regulatory approval letter and does not contain any information about the acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI or performance metrics typical of studies proving device effectiveness.
The document primarily states that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. It covers administrative aspects such as classification, general controls, and compliance with regulations.
Therefore, I cannot provide the requested information based on the content of 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.