(112 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR880.6250)
This device is not intended to be used as a chemical barrier.
Textured (Fingers & Palm) Powder Free Nitrile Exam Gloves (Black color)
This is an FDA 510(k) clearance letter for "Textured (Fingers & Palm) Powder Free Nitrile Exam Gloves (Black Color)" and does not contain details about acceptance criteria, device performance, or a study report typical for AI/ML-based medical devices.
The document states that the device is substantially equivalent to legally marketed predicate devices, which means its safety and effectiveness are established by comparison to an existing device rather than through a detailed performance study with explicit acceptance criteria for AI model performance.
Therefore, I cannot provide the requested information based on the provided text. The questions asked are relevant to the evaluation of AI/ML software as a medical device, which is a different regulatory pathway and requires different types of documentation than what is presented here for examination gloves.
§ 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.