(42 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powdered Green Latex Examination Gloves (Polymer Coated)
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for "Powdered Green Latex Examination Gloves (Polymer Coated)."
It states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. However, it does not include details about specific performance acceptance criteria or a study that rigorously demonstrates the device meets those criteria. The letter primarily focuses on regulatory approval based on substantial equivalence, rather than providing a detailed technical study report.
§ 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.