(35 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powdered Green Latex Examination Gloves
This document is a 510(k) clearance letter from the FDA for "Powdered Green Latex Examination Gloves." This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria.
The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving specific performance metrics against pre-defined acceptance criteria through a detailed study like one would find for a novel or high-risk device.
Therefore, I cannot provide the requested information based on 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.