(72 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder-Free Nitrile Examination Gloves, Peppermint Scented, Blue Color
The provided text is a 510(k) clearance letter from the FDA for Powder-Free Nitrile Examination Gloves. It does not contain any information about acceptance criteria or a study that proves a device meets such criteria.
The letter is a regulatory document confirming that the device is substantially equivalent to a predicate device and can be marketed. It details the product name, regulation number, product code, and clarifies regulatory compliance requirements.
Therefore, I cannot provide the requested 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.