(119 days)
The B-Care Powder Free, Latex Examination Gloves is a disposable device intended for medical purposes that is worn on examiner's hands or finger to prevent contamination between patient and examiner. (21 CFR 880.6250)
B-Care Powder Free, Latex Examination Gloves
The provided document is a 510(k) premarket notification letter from the FDA regarding B-Care Powder Free, Latex Examination Gloves. It primarily addresses the substantial equivalence determination for a medical device and does not contain information about the acceptance criteria or a study proving that a device meets specific acceptance criteria.
Therefore, I cannot provide the requested information based on the given document.
§ 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.