(58 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the exar iner's hand or finger to prevent contamination between patient and examiner.
Powder-Free Non-Sterile Vinyl Examination Gloves
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets any acceptance criteria. The document is a 510(k) clearance letter from the FDA for "Vinyl Exam Gloves, Powder-Free," indicating that the device has been determined to be substantially equivalent to a legally marketed predicate device.
The information provided only discusses:
- The FDA's decision to allow the marketing of the device.
- The regulatory class and product code.
- General controls provisions.
- Directions for further information or questions regarding labeling, promotion, and advertising.
- The "Indications For Use" statement for the gloves.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications, as this information is not present in the provided text.
§ 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.