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510(k) Data Aggregation
(44 days)
The Disposable Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. The subject device is clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.
The provided document is a 510(k) summary for a medical device called "Disposable Vinyl Examination Glove." It details the non-clinical testing performed to demonstrate that the device meets acceptance criteria and is substantially equivalent to a predicate device.
Here's the information broken down according to your request:
Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length (mm): ≥230 | Length: ≥230/ Pass |
| Width (mm): XS: 75±5; S: 85±5; M: 95±5; L: 105±5; XL: 115±5 | XS: 74-77/ Pass | ||
| S: 83-87 /Pass | |||
| M: 96-97/ Pass | |||
| L: 104-108/ Pass | |||
| XL: 114-117/ Pass | |||
| Thickness (mm): Finger: ≥0.08; Palm: ≥0.08 | Finger: 0.09-0.14/Pass | ||
| Palm: 0.10-0.13/Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 1.5 | 0/125 leaks / Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 |
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