(36 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
POWDERED NITRILE EXAMINATION GLOVE
I am sorry, but the provided document is a 510(k) clearance letter from the FDA for a Nitrile Examination Glove, not a medical device that uses AI or requires a study with acceptance criteria and performance metrics in the way you've described.
The document discusses:
- The FDA's review of a 510(k) notification.
- The determination of substantial equivalence to a legally marketed predicate device.
- Regulatory classifications and general controls provisions of the Act.
- Indications for use for the glove: "This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."
Therefore, I cannot provide the information you requested about acceptance criteria, study details, sample sizes, ground truth establishment, or AI-related metrics because it is not relevant to the subject matter of this 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.