(65 days)
The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Chlorinated Powder-Free Latex Examination Glove With Protein Content Labeling Claim (50 Micrograms or less)
I am sorry, but based on the provided document, there is no information available regarding acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a chlorinated powder-free latex examination glove, confirming its substantial equivalence to a legally marketed predicate device.
The letter discusses regulatory classifications, general controls, and compliance with Good Manufacturing Practice, but it does not detail specific performance acceptance criteria for the glove or any studies conducted to demonstrate its performance against such criteria. The "Indications For Use" section simply states the intended purpose of the glove.
§ 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.