(57 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Disposable Powder Free Vinyl Exam Glove, Yellow Color
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves a medical device meets specific acceptance criteria.
The document is an FDA 510(k) clearance letter for a "Disposable Powder Free Vinyl Exam Glove, Yellow Color". It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations that apply. It also includes an "Indications for Use Statement".
However, it does not contain any of the following information requested:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document pertains to the regulatory clearance of a basic medical glove, which typically does not involve the kind of performance studies or detailed acceptance criteria described in your request, often associated with software or more complex diagnostic/therapeutic devices.
§ 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.