(72 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.
SMARTFEEL Pre Powdered Nitrile Examination Gloves (Blue, Green and Natural Colors)
The provided document is a 510(k) premarket notification letter from the FDA regarding "SMARTFEEL Pre Powdered Nitrile Examination Gloves." This document does not contain information about acceptance criteria or a study proving device performance in the context of medical devices that require such studies (e.g., AI/ML algorithms, diagnostic tools, or therapeutic devices with performance metrics like sensitivity, specificity, accuracy, etc.).
This document is an approval letter for a Class I medical device, which are typically subject to general controls and substantial equivalence to a predicate device. For examination gloves, the "performance" is generally established through physical properties (e.g., tensile strength, resistance to tearing, barrier integrity) and biocompatibility, often demonstrated through adherence to recognized standards rather than clinical performance studies with specific statistical acceptance criteria as would be described for an AI/ML or diagnostic 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.