(37 days)
A patient examination gloves 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.
Powder Free Vinyl Synthetic Examination Gloves, White Color (Sensi-Pro)
I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for "Disposable Powder Free Vinyl Synthetic Examination Gloves White Color (Sensi-Pro)". It establishes the device's substantial equivalence to previously marketed devices and outlines regulatory compliance.
The document does not describe:
- Any acceptance criteria for device performance.
- Any study proving acceptance criteria.
- Sample sizes for test sets or training sets.
- Data provenance, expert qualifications, or ground truth establishment.
- Any multi-reader multi-case studies or standalone algorithm performance.
Therefore, I cannot fulfill your request based on the provided input.
§ 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.