(33 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powderfree Green Nitrile Examination Gloves (Polymer Coated)
The provided document is a 510(k) clearance letter from the FDA for Powderfree Green Nitrile Examination Gloves. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically found in an AI/Software as a Medical Device (SaMD) submission. The document primarily focuses on clearing the device based on substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information from this document. If you have a different document that details acceptance criteria and performance studies for an AI/SaMD, please provide it.
§ 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.