(53 days)
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Vinyl Examination Gloves
The provided documents are a letter from the FDA regarding a 510(k) premarket notification for "Powder Free Vinyl Examination Gloves" and an "INDICATION FOR USE" statement for the same device. These documents do not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications necessary to answer the prompt.
The letter is a notification of substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market their product. It does not include a technical evaluation or performance study report.
Therefore, I cannot provide a detailed response to the prompt's requirements based on the given information.
§ 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.