(120 days)
WA Rubbermate Powder-Free Latex Examination Gloves are a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
WA Rubbermate Powder Free Latex Examination Gloves
This document is a letter from the FDA regarding a medical device submission (K021041) for "WA Rubbermate Powder Free Latex Examination Gloves." It is a 510(k) clearance letter, indicating substantial equivalence to a predicate device.
This document does not contain information about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/ML device.
The provided text focuses on the regulatory aspects of clearing basic medical gloves, which are subject to general controls and not typically supported by the types of studies and performance metrics detailed in the request. Therefore, I cannot extract the requested information 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.