(64 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to patient and prevent contamination between examiner.
Powderfree Latex Examination Gloves Polymer Coated
The provided document is a 510(k) premarket notification letter from the FDA for Powderfree Latex Examination Gloves. It does not contain information about acceptance criteria, study details, or device performance metrics typically associated with AI/ML devices or complex medical equipment. The letter confirms substantial equivalence of the gloves to previously marketed devices based on the stated indications for use, but it doesn't involve testing against specific performance criteria as would be the case for a more advanced device.
Therefore, I cannot provide the requested information for acceptance criteria and the study that proves the device meets them because the provided text does not contain any of this information. It is a regulatory clearance document for a low-risk medical device (examination gloves) that doesn't typically require extensive performance studies with AI/ML-related metrics or expert ground truth adjudication.
§ 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.