(49 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner.
Purple Nitrile Patient Examination Glove, Powder-free
The provided text is an FDA 510(k) clearance letter for "Nitrile Patient Examination Gloves, Powder-Free, Purple." It describes the classification of the device and legal requirements for marketing but does not contain information about acceptance criteria or specific studies demonstrating device performance.
Therefore, I cannot provide the requested information from the text you provided. The document explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device would bove and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
And later:
"This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."
This indicates that the clearance is based on substantial equivalence to a predicate device, not on new studies proving specific performance metrics against acceptance criteria for this particular device. Such performance data would typically be found in the 510(k) submission itself, not in the FDA clearance letter.
§ 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.