(64 days)
A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
POWDER FREE LATEX EXMAINATION GLOVES
This document, K071322, is a 510(k) premarket notification for Powder Free Latex Examination Gloves. It is a regulatory clearance letter from the FDA, and as such, it does not contain the detailed technical study information typically found in a scientific publication or clinical trial report that describes acceptance criteria and device performance in the way requested.
Therefore, I cannot provide a direct answer to your request regarding acceptance criteria and a study proving the device meets them from the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the regulatory requirements for this class of device based on comparisons to existing products, rather than presenting a novel study designed to establish new performance criteria.
Here's why each of your requested points cannot be extracted from this specific document:
- A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria (e.g., tensile strength, viral barrier effectiveness) or present results from tests against such criteria. It's a regulatory clearance letter, not a performance report.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or mentioned.
- Adjudication method: Not applicable or mentioned.
- 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 applicable. This device is a physical glove, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical glove, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic "ground truth." For gloves, "ground truth" might refer to established physical properties and barrier effectiveness, but this document does not detail the testing.
- The sample size for the training set: Not applicable. Examination gloves do not typically involve "training sets" in the machine learning sense.
- How the ground truth for the training set was established: Not applicable.
§ 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.