(113 days)
A powdered patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand or finger (s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Powdered Latex Examination Gloves, Non-sterile
This document is a 510(k) clearance letter from the FDA for "Multisafe Powdered Latex Examination Gloves, Nonsterile." It does not contain any information regarding acceptance criteria, study details, or device performance metrics like sensitivity, specificity, or accuracy that would be relevant to AI/ML medical devices.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It refers to general controls, GMP regulations, and labeling requirements.
Therefore, it is impossible to extract the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) for an AI/ML device from this document.
§ 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.