(105 days)
A patient examination glove 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 Latex Examination Gloves
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for "Latex Examination Gloves, Powder Free". It indicates that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.
The letter pertains to regulatory clearance and does not include details about:
- Specific acceptance criteria (like performance metrics, accuracy thresholds, etc.)
- A study proving the device meets acceptance criteria (e.g., clinical trial results, performance data)
- Sample sizes for test or training sets
- Data provenance or ground truth establishment
- Details about expert involvement, adjudication, or MRMC studies
Therefore, I cannot fulfill your request based on the provided text.
§ 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.