(46 days)
A medical glove is wom on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
OmniGrace Nitrile, Blue, Examination Glove, Powder Free, Polymer Coated.
This document is a 510(k) premarket notification decision letter from the FDA to OmniGrace (Thailand) Ltd. regarding their Nitrile, Blue, Powder-Free, Polymer Coated Patient Examination Glove. The letter indicates that the device has been found substantially equivalent to devices marketed prior to May 28, 1976.
Unfortunately, this document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria. The provided text is a regulatory approval letter and an "Indications for Use Statement," not a study report or a detailed description of performance testing.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, or training set details. This information would typically be found in the 510(k) submission itself, or in subsequent test reports, which are not part of 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.