(35 days)
Powdered Latex Examination Gloves are worn on the hands of health care and Formilar personnel to prevent contamination between health care personnel and the patient.
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This document is a 510(k) clearance letter from the FDA for "Powdered Latex Examination Gloves." It is a regulatory document and does not contain any information about acceptance criteria, study details, or device performance metrics typically associated with AI/ML-based medical devices.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on quantitative performance parameters or clinical study results as asked in your prompt.
§ 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.