(41 days)
A vinyl 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.
POWDER FREE VINYL EXAMINATION GLOVES
The provided document is a 510(k) premarket notification letter from the FDA to General Gloves Corporation regarding "Powder Free Vinyl Examination Gloves." This document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
It primarily serves as:
- A confirmation of the FDA's review and their determination of substantial equivalence for the device to legally marketed predicate devices.
- An authorization for General Gloves Corporation to market the device, subject to general controls of the Act.
- A reminder of the company's responsibilities under various FDA regulations.
- A statement of Indications for Use for the device.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document. The document is a regulatory approval letter, not a detailed 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.