(52 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powderfree Latex Examination Gloves
I am sorry, but based on the text provided, there is no information about acceptance criteria or a study proving that a device meets any such criteria. The document is a letter from the FDA to a medical device manufacturer, acknowledging a 510(k) premarket notification for "Powderfree Latex Examination Gloves" and stating that the device is substantially equivalent to legally marketed predicate devices.
The letter discusses regulatory classifications, general controls provisions of the Act, and contact information for further inquiries. The "Indications For Use" section merely defines what a patient examination glove is and its intended purpose.
Therefore, I cannot provide the requested information as it is not present in the given text.
§ 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.