(98 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.
Latex Examination Gloves Polymer Coated (Powder-Free)
This looks like a 510(k) clearance letter for latex examination gloves, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML specific performance metrics is not applicable to this document.
The document states that the device is "substantially equivalent" to predicate devices, which is the standard for 510(k) clearance for many medical devices, particularly those that are well-established.
Therefore, I cannot provide the information requested in the format of the table or answer the specific questions related to AI/ML device studies.
§ 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.