(53 days)
THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Nitrile Examination Gloves, Pre-Powdered, Blue Glove
This document is a letter from the FDA regarding a 510(k) premarket notification for "Nitrile Examination Gloves, Pre-Powdered, Blue Glove". It confirms that the device is substantially equivalent to legally marketed predicate devices.
The information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not present in this document. This letter is a regulatory approval document and does not contain details of the performance study itself. It only states that the device was found substantially equivalent for its intended use, which is "for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."
§ 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.