(63 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, Blue, White, Pink, Black and Gray Color.
The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves." This document does not describe the acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
Therefore, I cannot extract the requested information from the provided text. The document is about regulatory approval, not device performance studies.
§ 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.