(45 days)
Pre-Powdered Patient Examination Gloves is a disposable device which is primarily intended for medical purpose worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
ROYAL IMPERIAL LATEX Pre-Powdered Patient Examination Gloves WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
This document is a 510(k) premarket notification from the FDA for a medical device: "Royal Imperial Powdered Latex Examination Gloves with Protein Control Labeling Claim (200 Micrograms or Less)". It's an approval letter, not a study report. Therefore, the requested information about acceptance criteria, device performance, ground truth, and study specifics cannot be extracted from the provided text.
The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the regulatory requirements for patient examination gloves. However, it does not contain the detailed technical specifications, test results, or study design information needed to answer your specific questions about acceptance criteria and how they were met.
§ 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.