(66 days)
Laglove™ Brand Colored Nitrile Examination Glove (Powder Free) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Laglove™ Blue Colored Nitrile Examination Gloves (Powder-Free)
The provided document is a 510(k) premarket notification letter from the FDA for a device described as "Laglove™ Blue Colored Nitrile Examination Gloves (Powder-Free)". This letter indicates a substantial equivalence determination, allowing the device to be marketed.
However, the document does not contain any information about acceptance criteria, a study proving the device meets those criteria, or details regarding the performance evaluation of the device in the context of your request.
The FDA 510(k) clearance process for devices like examination gloves primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive efficacy studies with detailed performance metrics as might be seen for more complex medical devices.
Therefore, I cannot provide the requested information based on the provided input. The document is merely an approval letter, not a study report or a detailed performance and acceptance criteria 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.