(74 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXANINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Environ-NP Powder Free Synthetic Vinyl Examination Gloves
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Environ-NP Powder Free Synthetic Vinyl Examination Gloves." It discusses the regulatory approval process and includes a general "Indications for Use" statement for patient examination gloves.
However, it does not describe any acceptance criteria, a specific study proving device performance against those criteria, or any details related to AI algorithms, ground truth, sample sizes for training/testing, expert adjudication, or MRMC studies.
Therefore, I cannot generate the table or answer the specific questions related to acceptance criteria and study details based on this document.
§ 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.