(52 days)
A Synthetic Vinyl 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.
Synthetic Vinyl Examination Glove, Powder Free
The provided document is a 510(k) premarket notification letter from the FDA regarding a "Synthetic Vinyl Examination Glove, Powder Free." This document is a regulatory approval letter and does not contain any information about acceptance criteria, study design, or performance metrics for the device itself.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, and it outlines the regulatory requirements the manufacturer must comply with.
Therefore, I cannot extract the requested information from this document. The questions you've asked are typically addressed in the submission's supporting data (e.g., performance testing reports), which are not included in this FDA 510(k) clearance letter.
§ 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.