(75 days)
A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the hand or finger to prevent contamination between examiner and patient.
Powder Free Nitrile Examination Glove, Non-sterile (Blue)
This document is an FDA 510(k) clearance letter for Powder Free Nitrile Examination Gloves. It does not contain any information about an AI/ML medical device, acceptance criteria, or performance study data.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The information requested (e.g., sample sizes, expert qualifications, ground truth, MRMC studies) is relevant to the evaluation of AI/ML devices, not to a simple medical device like examination gloves.
§ 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.