(21 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER, TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
The provided text is a 510(k) substantial equivalence determination letter from the FDA for "Disposable Vinyl Synthetic Examination Gloves, Powder Free". This document is a regulatory approval and does not contain information about acceptance criteria or a study proving that a device meets those criteria for software or AI medical devices.
The document discusses:
- The device name and its regulatory classification.
- The FDA's determination that the device is substantially equivalent to a legally marketed predicate device.
- General controls and requirements under the Federal Food, Drug, and Cosmetic Act.
- Indications for Use for the gloves (to prevent contamination between patient and examiner).
Therefore, I cannot extract the requested information as it is not present in the provided text. The questions posed pertain to the analytical validation of AI/ML or complex diagnostics, which is a different type of submission and data than what is found in this specific 510(k) clearance letter for examination gloves.
§ 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.