(32 days)
A patient examination Latex Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Latex Powder Free Examination Glove
This document is a 510(k) clearance letter for a "Latex Powder Free Examination Glove." It does NOT contain information about acceptance criteria or a study proving device performance in the context of an AI/software as a medical device (SaMD).
The letter simply states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it has met the regulatory requirements for this type of medical device (a physical glove) to be marketed, but there are no performance metrics or clinical study details as would be expected for a SaMD.
Therefore, I cannot provide the requested information for an AI/SaMD according to the provided text. The document pertains to a physical medical device (examination glove) and its regulatory clearance based on substantial equivalence, not a software device with performance criteria.
§ 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.