(73 days)
Latex Examination powdered glove is a disposable device intended for Medical purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.
Latex Examination Powdered Gloves
I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for "Latex Examination Powdered Gloves," indicating that the device has been determined to be substantially equivalent to a legally marketed predicate device.
The document discusses the regulatory classification, general controls, and market authorization for the gloves. It also includes an "Indications for Use Statement" for the product. However, it does not contain any details about performance metrics, study designs, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.
Therefore, I cannot provide the requested information in the specified format.
§ 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.