(42 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 examine.
Latex Patient Examination Gloves, Powder-Free (with Protein Content Claim (50hicrogram or less) Labelling of Powder-Free)
This document is a 510(k) premarket notification decision letter from the FDA regarding a latex, powder-free examination glove. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document confirms that the device is substantially equivalent to a predicate device marketed before May 28, 1976.
Therefore, I cannot provide the requested information based on 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.