(71 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Powdered Synthetic Vinyl Patient Examination Gloves, Yellow
The provided text is a 510(k) premarket notification letter from the FDA to Long First (Xiamen) Plastics Company Limited regarding their "Brothers Powered Synthetic Vinyl Patient Examination Gloves Yellow." This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter is a regulatory approval document stating that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory compliance, labeling, and other administrative aspects, but not performance testing details.
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.