(62 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
This document is a letter from the FDA regarding the approval of "Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color." It grants premarket notification to Canopus Medical Supply Company Limited.
The document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence to legally marketed predicate devices, not an evaluation of performance against specific acceptance criteria for this new device.
Therefore, I cannot provide the requested information from this document.
§ 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.