(70 days)
A patient examination Vinyl Powder Free Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Vinyl Powder Free Examination Glove
I am sorry, but the provided text from the FDA 510(k) K091429 document for "Vinyl Powder Free Examination Glove" does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance.
The document is a letter from the FDA determining substantial equivalence for the device. It discusses regulatory matters, such as classification, general controls, and compliance with various FDA regulations. It also includes the "Indications for Use" statement for the glove.
However, it does not contain:
- A table of acceptance criteria and reported device performance.
- Details about a study (sample size, data provenance, expert involvement, adjudication, MRMC study, standalone performance).
- Information on ground truth establishment for either test or training sets.
This type of detailed performance data and study design information is typically found in the sponsor's 510(k) submission itself, which is a much more extensive document than the FDA's decision letter provided here.
§ 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.