(40 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Matang Powder-Free Latex Patient Examination Gloves with Matang - San Protein Content Labeling Claim of 50 Micrograms or less of total water extractable protein per gram.
The provided text is a Premarket Notification (510(k)) for Powder Free Latex Patient Examination Gloves with Aloe Vera and a Protein Content Labeling Claim of 50 Micrograms or Less of Total Water Extractable Protein Per Gram. This document is a regulatory submission to the FDA, not a study report describing the performance of an AI/ML powered device.
Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the given text.
The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, meaning its safety and effectiveness are considered comparable. The key focus of this submission is on the regulatory classification and the labeling claim regarding protein content.
§ 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.