(78 days)
The Nitrile Exam Gloves, Powder Free, Blue are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
Nitrile Exam Gloves, Powder Free, Blue
This document is a 510(k) clearance letter for Nitrile Exam Gloves. It confirms that the device is substantially equivalent to a legally marketed predicate. However, it does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.
Specifically, the letter is an administrative document from the FDA clearing the device for market. It focuses on regulatory compliance (e.g., registration, listing, good manufacturing practices, labeling) and the substantial equivalence determination, rather than performance studies with acceptance criteria.
Therefore, I cannot provide the requested information based on 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.