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510(k) Data Aggregation
(204 days)
A powder-free 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.
The Powder-Free, Natural Color, Latex Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.
The provided documents describe the performance testing of "BPG Latex Examination Gloves" (Powder-Free, Natural Color, Latex Examination Gloves, Non-Sterile) to demonstrate substantial equivalence for a 510(k) submission.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| CHARACTERISTICS | ACCEPTANCE CRITERIA (STANDARDS) | REPORTED DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | D 3578-01a2 | Meets |
| Physical Properties | D 3578-01a2 | Meets |
| Freedom from Pinhole | D 3578-01a2 & FDA CFR 800.20 (FDA 1000 ml Water Leak Test) | Meets (Specifically states it meets FDA 1000 ml Water Leak Test) |
| Powder Amount | D 3578-01a2 & D 6124 - 05 |
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