(60 days)
This glove is disposable and intended for medical purposes to be worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Examination Gloves, Powder Free
This is an FDA 510(k) clearance letter for Nitrile Examination Gloves, Powder Free. It's a regulatory document, not a scientific study report. Therefore, it does not contain the detailed information required to describe acceptance criteria and a study proving device performance as requested in the prompt.
The document states that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on a comparison to existing devices, and typically for Class I devices like examination gloves, performance testing is done to demonstrate that the new device meets established standards or is equivalent to the predicate device. However, the details of such testing (acceptance criteria, specific study designs, sample sizes, ground truth) are not included in this clearance letter.
Therefore, I cannot provide the requested information from this document.
§ 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.