(47 days)
Midas Touch™ Purple Nitrile Examination Gloves- Polymer coated, Powder free, is a disposable patient examination glove, which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Midas Touch™ Purple Nitrile Examination Gloves- Polymer coated, Powder free
This document is a 510(k) clearance letter from the FDA for a medical device, specifically examination gloves. This type of document does not contain details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies as these are typically found in the 510(k) submission itself, not the clearance letter.
Therefore, I cannot provide the requested information from the provided text. The letter only confirms that the device is substantially equivalent to a predicate device and can be marketed subject to general controls.
§ 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.