(70 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES
This document is a 510(k) clearance letter from the FDA for "DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES." The letter confirms that the device is substantially equivalent to legally marketed predicate devices.
The information provided does not contain details about acceptance criteria, a study proving the device meets those criteria, or any of the specific points requested (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information).
This document is solely an FDA clearance letter for a medical device (examination gloves), indicating that it can be legally marketed. It does not contain the kind of performance data or study details you are asking for, which would typically be found in a separate study report or regulatory submission appendix.
§ 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.