(65 days)
Powder free vinyl 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 Vinyl Patient Examination Gloves, Clear (Non-Colored)
This document is a 510(k) premarket notification decision letter from the FDA for Powder Free Vinyl Patient Examination Gloves. It does not contain information about acceptance criteria or performance studies of a device in the traditional sense of AI/Software as a Medical Device (SaMD) evaluations.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. This substantial equivalence is typically demonstrated through comparing the device's technological characteristics and performance to a predicate device, as outlined in FDA guidance for medical devices, particularly for accessories like examination gloves.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this document does not contain that type of technical performance evaluation for a software or AI device. The "performance" in this context refers to the physical properties of the gloves (e.g., integrity, strength) and their intended use as a barrier, not to an algorithm's diagnostic or predictive capabilities.
§ 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.