(48 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
The provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria.
The document is a letter from the FDA to a medical device manufacturer, stating that their "Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color" have been found substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements for marketing the device.
Therefore, I cannot provide the requested information about acceptance criteria and a study to prove they are met based on this 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.