(275 days)
Patient examination gloves are "disposable medical devices intended for medical purposes that are worn on the examiner's hand to help prevent contamination between patient and examiner".
Latex Patient examination gloves, Powder Free
This document is a 510(k) clearance letter from the FDA for "Powder-Free, Latex Patient Examination Gloves." It does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria.
The letter simply states that the FDA has reviewed the submission and determined the device is "substantially equivalent" to legally marketed predicate devices. It does not provide:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, or ground truth establishment.
- Information on expert adjudication, MRMC studies, or standalone algorithm performance.
- Any specifics on the studies conducted to demonstrate the device's performance.
The letter is a regulatory approval, not a scientific study report. Therefore, I cannot fulfill your request with the provided input.
§ 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.