(42 days)
A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient
Powder-Free Nitrile Examination Glove, (Purple)
The provided text is an FDA 510(k) clearance letter for Powder-Free Nitrile Examination Gloves. It primarily confirms the device's substantial equivalence to a predicate device and outlines general regulatory obligations.
Therefore, the document does not contain any information regarding:
- Acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, accuracy, etc.)
- Details of a study proving the device meets acceptance criteria.
- Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Multi Reader Multi Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth used.
- Sample size or ground truth establishment for a training set.
The 510(k) process for devices like examination gloves typically relies on demonstrating substantial equivalence to a legally marketed predicate device, often through conformance to recognized standards (e.g., ASTM standards for glove integrity) and bench testing, rather than complex clinical studies with AI components, ground truth, or expert review panels.
In summary, none of the requested information about acceptance criteria or specific study details for proving performance is available in the provided text. The document focuses on regulatory clearance based on substantial equivalence.
§ 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.