(47 days)
Laglove™ Brand Nitrile Examination Glove (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Laglove™ Brand Nitrile Examination Gloves (Powdered)
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for Laglove™ Brand Nitrile Examination Gloves (Powdered). It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.
The letter does not contain details about:
- 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 establishing ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Types of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
The document primarily focuses on the regulatory clearance for the gloves, stating their intended use and classification.
§ 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.