(14 days)
As a medical glove, worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Powder-Free, Poly-Coated Nitrile Examination Glove, Purple or White (noncolored)
This document is a 510(k) clearance letter from the FDA for a medical device: "Powder-Free Nitrile, Poly-Coated Examination Glove, Purple or White (Non-colored)".
The information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document.
This letter is a regulatory approval notice, indicating that the device has been found substantially equivalent to a pre-existing legally marketed device. It does not contain the detailed technical performance study results, acceptance criteria, or specific ground truth methodologies that would typically be found in a 510(k) submission's performance data section.
Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance criteria based on the provided text.
§ 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.