(30 days)
LAGLOVE™ Brand Blue Color Latex Examination Glove, Powder Free containing 50 µgm or less of water extractable protein per gram is a disposable device intended for medical purposes that is worn on the hand of a healthcare provider or examiner to cover and protect against contamination between patient and examiner.
LAGLOVE™ Brand Blue Color Latex Examination Gloves, Powder Free containing 50 µgm or less of water extractable protein per gram.
The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or any details related to a study proving the device meets acceptance criteria.
The 510(k) clearance process primarily establishes "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive performance studies with specific acceptance criteria in the same way a PMA (Premarket Approval) might.
Therefore, I cannot fulfill your request for detailed information about acceptance criteria and a study from the provided input because that information is not present.
§ 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.