(102 days)
Latex Powdered Examination Glove with Protein Labeling Claim of 200 Microgram or Less Per Gram of 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.
Latex Powdered Examination Gloves with Protein Labeling Claim of 200 Microgram or Less Per Gram of Glove
I am sorry, but the provided text describes the FDA 510(k) premarket notification for Latex Powdered Examination Gloves. It does not contain any information about a medical device that utilizes AI or machine learning, nor does it discuss acceptance criteria, study methodologies, or performance metrics for such a device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves a device meets the acceptance criteria based on this document. The information you are asking for (e.g., sample sizes, expert qualifications, ground truth methods, MRMC studies) is completely absent from this FDA approval letter for 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.