(146 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves, Black Powder Free Nitrile Examination Gloves, Blue, Grape Scented
This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves." It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.
The letter is a standard FDA communication confirming that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements that the manufacturer must adhere to.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set size, or ground truth establishment for the training set) from the provided text. This information would typically be found in a separate study report or regulatory submission document describing the performance testing.
§ 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.