(294 days)
A patient examination glove is a disposable device intended for medical purpose that A partient chanination goss hands or finger to prevent contamination between patient and examiner.
VINYL PATIENT EXAM GLOVES PRE-POWDERED, CLEAR
This document is a letter from the FDA regarding a 510(k) premarket notification for "VINYL PATIENT EXAM GLOVES PRE-POWDERED, CLEAR." It is a regulatory approval document and does NOT contain information about acceptance criteria or a study that proves a device meets such criteria.
Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence to predicate devices, not on specific performance studies or acceptance criteria for the new device.
§ 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.