(195 days)
A Latex Powder Free examination glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient
Latex Powder-Free Examination Gloves
This document is a 510(k) clearance letter from the FDA for "Latex Powder-Free Examination Gloves." It is not a study demonstrating the performance of an AI-powered medical device. Therefore, it does not contain the information requested in the prompt.
The document discusses:
- The FDA's review of a premarket notification (510(k)) for examination gloves.
- The determination of substantial equivalence to legally marketed predicate devices.
- The classification of the device (Class I) and applicable regulations.
- The intended use of the gloves ("worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient").
There is no mention of acceptance criteria for an AI device, study results, sample sizes, expert ground truth, MRMC studies, or training sets for AI.
§ 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.