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510(k) Data Aggregation
(16 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, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.
The provided text describes the acceptance criteria and performance data for "Powdered Nitrile Examination Gloves" by SPI GLOVES SDN. BHD. This is a medical device and the information is presented as part of a 510(k) summary submitted to the FDA.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (ASTM D3578-01aE2 or FDA requirement) | Reported Device Performance (POWDERED NITRILE EXAM GLOVES AQL=2.5%) |
|---|---|---|
| 1. Watertight (1000 ml) | G I (AQL=2.5%) | Pass GI (AQL=2.5%) |
| 2. Length (mm) - various sizes | Min 230 | 240 mm minimum for all sizes |
| 3. Palm width (mm) - XS | - |
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