(9 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hands or finger to prevent contamination between parpose nation and examiner.
Not Found
The requested information is not available in the provided text. The document is a 510(k) substantial equivalence letter from the FDA for "Powder-Free Vinyl Exam Gloves." It does not contain details about specific acceptance criteria or a study proving the device meets those criteria. Instead, it confirms that the device is substantially equivalent to a legally marketed predicate device based on its intended use.
The document discusses regulatory information, labeling requirements, and contact information, but not performance study data of the type requested.
§ 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.