(173 days)
A 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.
Elastyren Powder-Free Patient Examination Gloves
The provided text is a 510(k) clearance letter from the FDA for "Elastyren Powder-Free Patient Examination Gloves." It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone algorithm performance).
The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated uses. It refers to general controls provisions of the Act (e.g., annual registration, good manufacturing practice) but does not detail specific performance-based acceptance criteria or the studies used to demonstrate those specific criteria for the gloves themselves.
Therefore, I cannot extract the requested information from 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.