(130 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.
Not Found
The provided text does not contain information about acceptance criteria for a device, a study proving the device meets said criteria, or any details related to AI/algorithm performance. The document is an FDA 510(k) clearance letter for "Gold Finger Latex Patient Examination Gloves, Powder-Free with water extractable protein labeling claim."
It primarily states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act.
Therefore, I cannot provide the requested information based on the input 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.