(55 days)
A 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.
Powder-free Latex Patient Examination Glove. with extractable protein content labelling claim (50 microgram per gram of glove or less)
The provided text is a 510(k) clearance letter from the FDA for a Powder-free Latex Patient Examination Glove. This document approves the marketing of a medical device and describes its intended use and conformance to general controls. It is not a study report that details acceptance criteria and device performance data from a specific study.
Therefore, the information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication method, MRMC study details, standalone performance, ground truth types, training set size, and ground truth establishment for training) cannot be extracted from this document.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, implying it meets the same general safety and effectiveness standards as those already on the market, but it does not present the specific results of a performance study against predefined acceptance 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.