(45 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthca personnel and patient.
Powder Free Synthetic Vinyl Patient Examination Gloves, Yellow
This document is a 510(k) premarket notification approval letter for "Powder Free Synthetic Vinyl Patient Examination Gloves, Yellow." It does not include information about acceptance criteria or a study proving that a device meets acceptance criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations that apply. It details the device name, regulation number, product code, and indications for use.
Therefore, I cannot provide the requested information as it is not present in the provided text.
§ 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.