(72 days)
A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Powdered Vinyl Synthetic Examination Gloves
This document is a 510(k) premarket notification decision letter from the FDA to Shinemound Enterprise, Incorporated, concerning "Powdered Vinyl Synthetic Examination Gloves."
The provided text is a regulatory approval document and does not contain information about acceptance criteria or a study proving the device meets criteria.
Therefore, I cannot provide the requested information. The document solely states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed for the indicated use (as a medical disposable glove worn by healthcare personnel to prevent contamination).
§ 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.