(73 days)
The glove is disposable and intended for Medical purpose that is worn on the examiner's hand to prevent contamination between the patient and the examiner.
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND - PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Latex Examination Gloves with Aloe Vera and Protein Content Labeling Claim (50 Micrograms or Less)." This type of regulatory document concerns the substantial equivalence of a medical device to a legally marketed predicate device, primarily focusing on its safety and effectiveness for its intended use.
The document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance). These details are typically found in the supporting documentation submitted with the 510(k) application, which is not provided in this extract.
Therefore, I cannot provide the requested information based on 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.