(112 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Smart Savers, Powder Free Nitrile Examination Gloves, Blue, White, Pink and Gray color
This document is a 510(k) premarket notification letter from the FDA to Platinum Glove Industries Sdn Bhd for their "Smart Savers, Powder Free Nitrile Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
The document does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth, or any other details related to AI/algorithm performance studies. The context of the request is entirely focused on what would be found in a study for an AI-powered medical device, which is not applicable here.
Therefore, I cannot provide the requested information based on 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.