(42 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Powder-Free Multi-Ply Latex Examination Gloves With Protein Labeling Claim ( 50 Micrograms or Less )
I am sorry, but based on the provided document, I cannot extract the information required to answer your request. The document is a 510(k) premarket notification letter from the FDA regarding "Powder-Free Multi-Ply Latex Examination Gloves With Protein Labeling Claim (50 Micrograms or Less)."
This document primarily focuses on the regulatory approval of a medical device (examination gloves) and does not contain details about:
- Acceptance criteria and reported device performance in a table format.
- Specific studies, sample sizes, data provenance, ground truth establishment, or expert qualifications.
- Adjudication methods or multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance or training set details.
The document is a letter confirming substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices, rather than a detailed study report.
§ 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.