(14 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.
This looks like a 510(k) premarket notification for examination gloves, which are low-risk devices. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the device meets established ASTM standards and FDA requirements for such products, rather than clinical efficacy trials common for higher-risk medical devices.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (ASTM D6319-00aE3 / FDA) | Reported Device Performance (POLYMER COATED POWDER FREE NITRILE EXAM GLOVES) |
|---|---|---|
| Watertight (1000 ml) | GI AQL=2.5% | Pass GI AQL=2.5% |
| Length (mm) | ||
| Size XS | Min 230 | 240 mm minimum for all sizes |
| S | Min 230 | 240 mm minimum for all sizes |
| M | Min 230 | 240 mm minimum for all sizes |
| L | Min 230 | 240 mm minimum for all sizes |
| XL | Min 230 | 240 mm minimum for all sizes |
| Palm width (mm) | ||
| Size XS | - |
§ 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.