(32 days)
Powdered 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.
powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard I) 525()-00'd
The provided text is for a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, White (Non-colored)." It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. The information focuses on regulatory compliance based on established standards rather than a study proving the device meets acceptance criteria through clinical or comparative effectiveness trials.
Here's a breakdown based on your request, highlighting the information that is not present in the provided document, as it's not typically required for this type of device and submission:
Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00e4 | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-00e4 | Meets |
| Biocompatibility: Primary Skin Irritation (Rabbits) | Not a Primary Skin Irritation (Implicitly: Passes standard for no irritation) | Passes ( |
§ 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.