(114 days)
a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.
Powder-Free Synthetic Vinyl Examination Gloves, Blue Color
This document is a 510(k) premarket notification decision letter from the FDA for Powder-Free Synthetic Vinyl Examination Gloves, Blue Color. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the provided information, but the letter itself does not include the details of the performance study or the acceptance criteria used in that study.
Therefore, I cannot provide the requested information based on the input document.
§ 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.