(15 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.
Powdered Latex Examination Gloves Without Protein Content Labelling Claim
This document is correspondence from the FDA regarding a 510(k) premarket notification for Powdered Latex Examination Gloves. It is not a study report or clinical trial. Therefore, none of the requested information regarding acceptance criteria, device performance, study details, or ground truth can be extracted from this document.
The document only states that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It does not contain any data on device performance or studies conducted to establish its effectiveness or safety beyond demonstrating substantial equivalence.
§ 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.