(126 days)
The 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.
Powder-Free Non-Sterile Vinyl Examination Glove
The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder-Free Non-Sterile Vinyl Examination Gloves." This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The letter is an approval for marketing the device based on its substantial equivalence to a legally marketed predicate device. It confirms that the device falls under general controls and lists various regulatory requirements that the manufacturer must adhere to. The "Indications for Use" section briefly states the intended purpose of the glove.
Therefore, I cannot extract the requested information from the provided input:
- A table of acceptance criteria and the reported device performance: Not present. The document does not discuss performance metrics or acceptance criteria for the gloves.
- Sample size used for the test set and the data provenance: Not present. No test data or study details are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment is described.
- Adjudication method: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This document does not pertain to AI or reader studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
This document is purely an FDA clearance letter for a medical device, not a scientific study report or a detailed performance specification 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.