(156 days)
A patient examination glove is a disposable device intended for medical purposes, that is worn on It pation oxamination grove is a sevent contamination between patient and examiner.
Colored Ambiderm Powder-Free Examination Gloves with Protein Labeling Claim. (White, Violet, Green, Yellow, Orange, Pink & Blue) .
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Ambiderma Colored Powder-Free Latex Examination Glove). This document confirms the device's substantial equivalence to a predicate device and permits its marketing.
However, it does not contain any information about acceptance criteria for device performance or details of a study conducted to prove the device meets such criteria. The letter focuses on regulatory approval based on equivalence, not on the results of a performance study with specific metrics, sample sizes, or ground truth establishment—which are typically found in a detailed study report or scientific publication.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
§ 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.