(74 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 examiner.
Polymer-Coated, Powder-free, Latcx Patient Examination Glove with Protein Labelling Claim (contain 50 microgram or less of total water extractable protein per gram)
There is no information about the acceptance criteria or a study proving device performance in the provided text. The document is an FDA 510(k) clearance letter for "Polymer Coated, Powder-Free Latex Examination Gloves."
This letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It discusses regulatory requirements and classification but does not contain details about specific performance metrics, clinical studies, or an AI device.
Therefore, I cannot provide answers to the requested points, as they are not present in the given 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.