(66 days)
A powdered patient examination glove is a disposable device made of latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.
GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
This document is a 510(k) clearance letter from the FDA for "Green Peppermint Flavored Powdered Latex Examination Gloves." This letter primarily addresses regulatory approval and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
The information provided (e.g., FDA logo, communication regarding a 510(k) notification, product name, indications for use) is typical of a regulatory clearance for a medical device that is a physical product (gloves in this case), not a software or AI/ML device.
Therefore, I cannot extract the requested information as it is not present in the provided text.
§ 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.