(52 days)
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR.
The provided document is a 510(k) clearance letter from the FDA for Nitrile Examination Gloves. It does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth, sample sizes, or expert qualifications for such studies.
The letter primarily:
- Confirms that the device is "substantially equivalent" to predicate devices.
- Outlines regulatory obligations for the manufacturer.
- Includes an "Indication For Use" statement for the gloves.
Therefore, I cannot provide the requested information based on the given 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.