(47 days)
A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
This device is not intended to be used as a chemical barrier.
Textured Powder Free BP2000 (Butadiene Polymer) Exam Gloves, Natural color
This document is a 510(k) clearance letter for "Textured Power-Free BP 2000 (Butadiene Polymer) Examination Gloves, Natural Color." It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes, expert involvement, or adjudication methods.
The document is a regulatory approval notice, not a study report. Therefore, I cannot extract the requested information from the given input.
§ 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.