(58 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Powder-free Latex Examination Glove
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves a device meets them. The document is a 510(k) clearance letter from the FDA for "Powder-free Latex Examination Gloves," indicating that the device is substantially equivalent to a legally marketed predicate device.
The information concerns regulatory approval for a medical device (latex examination gloves) and does not include details about device performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment. These are typically found in the 510(k) submission itself, not in the clearance letter.
§ 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.