(81 days)
CIR latex examination glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment.
CIR Latex Gloves, Non-Sterile, Powdered [Latex Examination Gloves (Powdered, Non-Sterile) with Protein Labeling Claim of ≤ 200 µg/g]
I am sorry, but based on the provided document, I cannot answer your request. The document is a letter from the FDA regarding a 510(k) premarket notification for "CIR Latex Examination Gloves, Non-Sterile, Powdered, with Protein Labeling Claim of 200uq/q or Less."
This document does not contain any information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication), or comparative effectiveness studies. It is a regulatory approval letter stating that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot extract the specific information you requested regarding the device's acceptance criteria and the study that proves it meets those criteria.
§ 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.