(263 days)
It is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
disposable device made of natural rubber latex material that may bear a trace amount of glove powder
The provided text is a 510(k) premarket notification letter from the FDA regarding "MOTEX Powder-Free Examination Gloves with Protein Labeling Claim (300 Micrograms or Less)." This document is a regulatory approval for a medical device and does not contain any information about a study involving AI, algorithms, or ground truth establishment relevant to the questions asked.
Therefore, I cannot provide answers to the specific questions because the document describes a physical medical device (gloves) and its regulatory classification, not a software-based device or a study with acceptance criteria and performance metrics typically associated with AI/ML evaluations.
§ 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.