(71 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Omni Touch Nitrile Examination Glove, Powdered, Purple
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for "Omni Touch Nitrile Examination Glove, Powdered, Purple," which confirms the device's substantial equivalence to predicate devices and permits its marketing.
The letter and the attached "Indications For Use Statement" do not detail:
- Specific acceptance criteria for the device beyond its intended use as a medical glove.
- Any performance study, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.
Therefore, I cannot fulfill your request with the provided information.
§ 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.