(165 days)
A 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 pariesoo and examiner. This device is not intended to be used as a chemical barrier.
Powder-free Nitrile Patient Examination Glove, White (non-colored) and Blue Colored, Tested for use with Chemotherapy Drugs
This document is a 510(k) premarket notification letter from the FDA regarding a Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue Colored, Tested for use with Chemotherapy Drugs.
The letter states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding specific acceptance criteria, device performance metrics, or study details (like sample sizes, ground truth establishment, or expert qualifications).
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.
§ 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.