(30 days)
LAGLOVE™ Brand Blue Color Latex Examination Glove, Powdered containing 150 µgm or less of water extractable protein per gram 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 Blue color Latex Examination Gloves, Powdered containing 150 μgm or less of water extractable protein per gram.
This document is a 510(k) clearance letter from the FDA for a medical device: LAGLOVE™ Brand Blue Color Latex Examination Gloves. It is not a study report. Therefore, it does not contain the information requested regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML powered medical device.
The letter explicitly states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This substantial equivalence is based on the device conforming to general controls provisions of the Act, which include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. It also mentions compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820).
Therefore, I cannot provide the requested information from this document. I would need a study report or clinical trial documentation for an AI/ML powered medical device to answer these questions.
§ 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.