(30 days)
A powder-free patient examination glove is a disposable device intended for medical purpose that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner.
Powder-Free Vinyl Non-Sterile Examination Glove
The provided text is a 510(k) clearance letter from the FDA for a Powder-Free Vinyl Non-Sterile Examination Glove. This document pertains to the regulatory clearance of a medical device, specifically a physical product (gloves), and not a digital health device or AI/ML-based software.
Therefore, the requested information about acceptance criteria for a device's performance, human reader studies, AI/ML training, and ground truth establishment is not applicable to this document. The FDA letter confirms the device's substantial equivalence to a legally marketed predicate device based on its intended use as a patient examination glove to prevent contamination, and its adherence to general controls and good manufacturing practices. There is no mention of a study involving performance metrics like sensitivity, specificity, or AUC, as these are typically associated with diagnostic or AI-driven devices.
§ 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.