(43 days)
The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Latex Examination Gloves, with Protein Labeling Claim - BLUE Total water extractable Protein claim.
The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder-Free Latex Examination Gloves (Blue)". This document does not contain any information regarding the acceptance criteria, device performance, study details, or ground truth establishment for a medical device that uses AI or machine learning.
The letter is a regulatory approval for a physical medical device (gloves) and focuses on substantial equivalence to predicate devices, general controls, and compliance with manufacturing practices. 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.