(43 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 examiners.
Powder-free Latex Examination Glove with Labeling Claim of 50 micrograms or less of total water extractable protein per gram.
This document is a FDA 510(k) clearance letter for a "Powder-Free Latex Examination Glove With Labeling Claim of 50 micrograms or less of total extractable protein per gram." It does NOT contain information regarding a study proving acceptance criteria for a device involving AI or complex performance metrics.
The letter simply states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the regulatory requirements for Class I medical devices based on its intended use and safety profile.
Therefore, I cannot provide the requested information as it is not present in the provided text. The criteria for "substantial equivalence" for this type of device are primarily related to material composition, manufacturing practices, and safety for its intended use (preventing contamination between patient and examiner), rather than complex performance metrics that would require the detailed studies outlined in your request.
§ 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.