(235 days)
Laglove TM Brand Nitrile Examination Gloves, Powder Free, Non - Sterile (Pink Color) is a patient examination glove is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.
Laglove ™ Brand Nitrile Examination Gloves, Powder Free, Non-Sterile. (Pink Color)
This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria and study details for a medical device's performance. The letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use and safety/effectiveness profiles.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details because 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.