(139 days)
The device is a disposable patient examination glove made of synthetic rubber intended for medical purposes. It is donned by the examiner on the hands to prevent possible contamination between patient and examiner (Tested for Chemo use).
Powderfree Chloroprene White, Pink, Blue and Green Colored Patient Examination Gloves (FLAVOR Strawberry, Peppermint, Tutty-Frutti)
The provided text is a clearance letter from the FDA for a patient examination glove and does not contain information about acceptance criteria or a study proving that a device meets such criteria. It primarily focuses on the substantial equivalence determination for marketing the device.
Therefore, I cannot answer your request based on the provided input.
§ 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.