(180 days)
A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
The provided text is a 510(k) Premarket Notification from the FDA for "Powder Free Nitrile (Blue and White) Examination Gloves." This document DOES NOT describe acceptance criteria or a study proving the device meets those criteria.
Instead, a 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This equivalence is typically based on:
- Same intended use.
- Same technological characteristics, OR
- Different technological characteristics but does not raise different questions of safety and effectiveness AND is as safe and effective as the predicate device.
For devices like examination gloves, equivalence is often established by demonstrating compliance with recognized consensus standards (e.g., ASTM standards for physical properties, barrier integrity, and biocompatibility). The FDA letter confirms the device's substantial equivalence to a predicate, allowing it to be marketed, but does not detail the specific performance criteria or studies that led to this determination within the provided text.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC comparative effectiveness studies from the provided text. This type of information would typically be found in the actual 510(k) submission document itself, not in the FDA's decision letter.
§ 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.