(90 days)
The powder Free Nitrile Examination Gloves (White, Cobalt Blue and Violet Blue) 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.
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)
I am sorry, but the provided text does not contain the information requested. The document is a 510(k) premarket notification letter from the FDA to Zibo Chengxun Automatic Device Co., Ltd regarding Powder Free Nitrile Examination Gloves. It primarily discusses the substantial equivalence determination for the device and regulatory compliance.
It does not include details about:
- Acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods for ground truth, or details of any comparative effectiveness studies (MRMC or standalone).
- The type or establishment of ground truth for testing or training sets.
§ 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.