(84 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETTERN PATIENT AND EXPMINER.
Environ-NF DISPOSABLE SYNTHETIC VINYL EXAM GLOVE, POWDER FREE (YELLOW)
The provided text is a 510(k) clearance letter from the FDA for a medical device: "Environ-NP Powder Free Synthetic Vinyl Examination Gloves." This document is a regulatory approval and does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the way a performance study for an AI/ML device would.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. The "indications for use" simply describe the intended purpose of the gloves (to prevent contamination between patient and examiner).
Therefore, I cannot provide the requested information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth types, as these are not present in the provided text.
§ 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.