(43 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.
Not Found
The provided text does not contain information about acceptance criteria and a study proving a device meets them. Instead, it is a 510(k) premarket notification letter from the FDA to PT. Smart Glove Indonesia regarding their Polymer Coated Powder Free Nitrile Examination Gloves.
This document indicates that the FDA has reviewed the company's application and has determined the gloves are substantially equivalent to legally marketed predicate devices. This means the device can proceed to market, subject to general controls.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment, as this type of information is not present in the provided 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.