(66 days)
Powderfree Vinyl Examination Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
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I'm sorry, but the provided text does not contain the information needed to answer your request. The document is a 510(k) clearance letter from the FDA for "Top Glove Powder-Free Vinyl Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document discusses:
- The device name and regulation number.
- The FDA's determination of substantial equivalence.
- The general controls provisions of the Act that apply to the device.
- Contact information for FDA offices.
- An "Indications for Use" statement for the gloves.
However, there is no mention of acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for a device. These concepts are typically associated with the evaluation of more complex medical devices, particularly those involving algorithms, imaging, or specific diagnostic/therapeutic claims, not with a basic product like examination gloves.
§ 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.