(413 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.
Powder-Free Latex Examination Gloves
This document is a 510(k) clearance letter from the FDA for Powder-Free Latex Examination Gloves. It does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically relies on demonstrating equivalence through comparison to an existing device, rather than requiring new clinical studies to establish performance against defined acceptance criteria.
Therefore, I cannot provide the requested information based on the provided text. The document indicates that the device is "substantially equivalent" to devices marketed prior to May 28, 1976, and outlines general regulatory compliance rather than specific performance metrics or studies.
§ 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.