(20 days)
The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Blue Chlorinated Powder Free Latex Examination Gloves With Protein Content Labeling Claim of 50 micrograms or less.
I am sorry. This document is a letter from the FDA regarding a 510(k) premarket notification for examination gloves. It confirms that the device is substantially equivalent to legally marketed predicate devices. The document specifies the indications for use for the gloves. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment for a medical device that would involve such detailed testing and analysis.
Therefore, I cannot provide the requested information based on the text provided.
§ 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.