(231 days)
A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Powder Free Vinyl Examination Gloves
I'm sorry, but without further context, I cannot fulfill your request for information about acceptance criteria and study results. The provided text is a letter from the FDA to a medical device company regarding the 510(k) clearance of "Powder Free Vinyl Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain the following information that you requested:
- A table of acceptance criteria and reported device performance. The FDA letter is a regulatory approval, not a performance study report.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone algorithm performance. (This is not an AI/algorithm device).
- Type of ground truth used.
- Sample size for the training set.
- How ground truth was established for the training set.
The document only states the "Indication For Use" for the gloves, which is: "A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient."
To answer your request, I would need a different type of document, such as a clinical study report, a scientific publication, or a detailed technical submission to a regulatory body that specifically outlines performance testing and acceptance criteria for a medical device that would not be typical of examination gloves.
§ 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.