(71 days)
A Vinyl examination glove, Powder Free, Clear(Non-Colored)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, Clear (Non-Colored)
I am sorry, but based on the provided text, I cannot extract specific information about acceptance criteria for a medical device's performance, the studies conducted, sample sizes, expert qualifications, or ground truth establishment.
The document is a US FDA 510(k) clearance letter for "Powder-Free Vinyl Gloves, Clear (Non-Colored)". It primarily concerns the regulatory process of determining substantial equivalence to a predicate device, rather than detailing scientific studies on device performance.
While it mentions "good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)", it doesn't provide specific test results or acceptance criteria for the gloves' performance as medical devices (e.g., barrier integrity, tensile strength). The listed "indications for use" simply describe the intended purpose of the 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.