(91 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Latex Examination Gloves, with Protein Labeling Claim. Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram, Natural Color
This document is a 510(k) clearance letter from the FDA for Powder Free Latex Examination Gloves. It does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement for an AI/ML powered device.
Therefore, I cannot provide the requested information. The provided text is solely a regulatory approval document for a medical device (gloves).
§ 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.