(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 prevent contamination between patient and examiner.
Powderfree Latex Examination Gloves ( Polymer Coated )
The provided text is a 510(k) premarket notification letter from the FDA regarding "Powderfree Latex Examination Gloves (Polymer Coated)." This document does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.
The letter is a notification of substantial equivalence for a medical device (examination gloves) and focuses on regulatory compliance for marketing the device. It discusses:
- The device's name and regulatory class.
- The determination of substantial equivalence to pre-amendment devices.
- General controls and potential additional controls applicable to the device.
- Information on marketing, labeling, and other regulations.
- The "Indications For Use" statement.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, ground truth, or expert involvement, as this data is not present in the provided document.
§ 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.