(38 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
SMART-FEEL Powder Free Nitrile Examanation Gloves. (Natural, BLUE & Green)
The provided document is a 510(k) premarket notification letter from the FDA regarding "Smart-Feel Powder Free Nitrile Examination Gloves." This document does not contain information about acceptance criteria or a study proving device performance against such criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. However, it does not involve the type of performance study typically conducted for AI/ML-driven medical devices that would have acceptance criteria and detailed study results. The information requested in your prompt (e.g., sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies) is not relevant or present in this specific type of regulatory document, as it pertains to a medical glove, not an AI software.
Therefore, I cannot provide the requested information based on the input 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.