(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 |
§ 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.