(376 days)
Powder-Free Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs) is a general purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.
Powder-Free Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
I am sorry, but the provided text from the FDA letter (K991422) is a 510(k) clearance letter for "Powder-Free Nitrile Examination Glove (Tested for Use with Chemotherapy Drugs)" and not a study that details acceptance criteria and device performance.
This document indicates that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed. However, it does not contain the specific information required to answer your questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies for a medical imaging or AI-driven diagnostic device.
Therefore, I cannot extract the requested information from 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.