(47 days)
Laglove™ Brand Nitrile Examination Glove (Powder Free) is a disposable patient examination glove which is worn on the hand of the examiner to prevent contamination between patient and examiner.
Laglove™ Brand Nitrile Examination Glove (Powder Free)
The provided document is a 510(k) premarket notification letter from the FDA regarding "Laglove™ Brand Nitrile Examination Glove (Powder-Free)". This type of document is a regulatory approval for a medical device and does not contain the detailed technical study information requested in your prompt.
Therefore, I cannot provide the specific information about:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone performance study details
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document only confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It states the indications for use are as "a disposable patient examination glove [worn] on the hand of the examiner to prevent contamination between patient and examiner." The regulatory class is I, and the product code is LZA.
To obtain the information you're looking for, you would typically need access to the actual 510(k) submission document, which would include performance data, test methods, and potentially a summary of clinical or non-clinical studies if required for that specific device type.
§ 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.