(36 days)
A patient examination glove that is worn by the healthcare or similar personnel to prever t contamination setween the healthcare and the patient.
Powdered Latex Examination Gloves with Protein Labeling Claim
The provided document is a 510(k) clearance letter from the FDA for "Latex Examination Gloves Powdered, with Trade Name: Protein Labeling Claim (50 Micrograms or Less Per Gram)". This document is a regulatory approval and does not contain the acceptance criteria or a study proving the device meets the acceptance criteria for an AI/ML powered device.
The letter states that the device is "substantially equivalent" to predicate devices, meaning it has similar indications for use, safety, and effectiveness. However, it does not detail specific performance metrics, sample sizes, expert ground truth, or study designs that would be relevant for evaluating an AI/ML diagnostic or screening device.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria based on the input document. The input relates to the regulatory approval of a physical medical device (gloves), not an AI/ML software device.
§ 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.