(35 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.
Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove, with Extractable Protein Content Labeling Claim (50 microgram per Gram of Glove or Less)
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for "Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove, with Extractable Protein Content Labeling Claim (50 microgram per Gram of Glove or Less)".
This document simply states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It does not contain any information about acceptance criteria for a study, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. This type of information would typically be found in a separate performance study report or design validation documentation, not in an FDA clearance letter.
§ 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.