(98 days)
Laglove TM Brand Latex Examination Gloves, Powdered, Non - Sterile (Pink, Green, Violet) is a patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Laglove ™ Brand Latex Examination Gloves, Powdered, Non-Sterile. (Pink, Green, Violet)
This document is a 510(k) clearance letter from the FDA for medical examination gloves and does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.
The letter confirms that the Laglove™ Brand Latex Examination Gloves, Powdered, Non-Sterile are substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance, labeling, and other general responsibilities under the Federal Food, Drug, and Cosmetic Act.
Therefore, I cannot provide 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.