(23 days)
A DISPOSAL DEVICE TO PREVENT CONTAMINATION BETWEEN THE PATIENT AND EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN THE PATIENT AND EXAMINER .
POWDER FREE ( TEXTURED ) LATEX EXAMINATION GLOVES ATTH PROTETH LABELLING CLAIMS ( 50 MICROGRAMS OR LESS )
This document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)." It is a regulatory approval document and does not contain the information requested regarding acceptance criteria or a study proving device performance in the context of an AI/medical device study.
Therefore, I cannot provide the requested information from the given text.
§ 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.