(49 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.
Latex Patient Examination Glove, Powdcred Type II, Low Modulus, with extractable protein content labelling claim (200 microgram per gram of glove or less)
This document is a 510(k) clearance letter for "Latex Examination Gloves, Powdered Type II, Low Modulus with Extractable Protein Content Labeling Claim (200 Micrograms or Less)". It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain information about acceptance criteria, device performance studies, or ground truth establishment typically found in detailed device validation reports.
The provided text focuses on the regulatory clearance process rather than technical performance data. Therefore, I cannot extract the requested information.
§ 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.