(43 days)
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for "Brothers Vinyl, Powdered, Patient Examination Gloves," indicating that the device has been found substantially equivalent to a legally marketed predicate device.
The document discusses:
- The FDA's review and determination of substantial equivalence.
- Regulatory classification (Class I).
- Applicable general controls provisions of the Act (annual registration, listing, GMP, labeling, misbranding, adulteration).
- Contact information for various FDA offices.
- The "Indications For Use" statement for the medical gloves.
There is no mention of specific performance metrics, acceptance criteria, study methodologies, sample sizes for test or training sets, expert qualifications, ground truth establishment, or comparative effectiveness studies. Therefore, I cannot extract the information you requested based on the input provided.
§ 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.