(28 days)
A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient
Powder-free Chlorinated Latex Examination Gloves with Protein Labeling Claim
The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder-free Chlorinated Latex Examination Gloves With Protein Labeling Claim". This document is a regulatory approval for a medical device (examination gloves) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical study for a diagnostic or therapeutic device would.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, those differences do not raise new questions of safety or effectiveness.
Therefore, I cannot extract the requested information as it is not present in the provided text. The questions typically pertain to studies involving the performance of a diagnostic or treatment device, often involving metrics like sensitivity, specificity, accuracy, and expert involvement for ground truth, which are not applicable to the 510(k) approval process for examination gloves as described here.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.