(56 days)
A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.
Powdered Latex Examination Gloves (Protein Label Claim) (50 microgram or less)
The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powdered Latex Examination Gloves." This letter grants market clearance based on a determination of substantial equivalence to a predicate device.
It does not contain information about acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, expert qualifications, or details of a study that proves the device meets acceptance criteria.
The letter explicitly states:
"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
This is a regulatory clearance based on substantial equivalence, not a detailed description of an efficacy or performance study. Therefore, I cannot generate the requested information 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.