(28 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.
Powder Free Nitrile Examination Gloves (White, Blue and Purple Color)
I am sorry, but based on the provided document, I cannot extract the information required to answer your request.
The document is an FDA 510(k) clearance letter for "Powder Free Nitrile Examination Gloves." It focuses on the regulatory approval process, substantial equivalence to predicate devices, and the intended use of the gloves.
There is no mention of:
- Acceptance criteria for device performance (other than the implied safety and efficacy for medical gloves).
- Any specific studies proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Expert qualifications or ground truth establishment.
- MRMC comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot populate the table or provide the detailed study information you requested.
§ 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.