(56 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.
Vinyl Patient Examination Gloves Powder-Free, Non-Sterile
The provided text is a letter from the FDA regarding the 510(k) premarket notification for "Vinyl Patient Examination Gloves Powder-Free, Non-Sterile." This type of document is a regulatory approval for a medical device and does not contain information about the acceptance criteria or a study proving the device meets those criteria, as requested in your prompt.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to a device already on the market. The FDA's determination of substantial equivalence does not involve clinical studies with acceptance criteria in the same way modern AI/software as a medical device (SaMD) validations do.
Therefore, I cannot extract the requested information from this document. The prompt asks for details typically found in a clinical validation study report for a software or AI-based medical device, which is not what this document is.
§ 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.