(170 days)
Nitrile 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.
Nitrile powder-free patient examination, that meets all of the requirements of ASTM standard D 6319-00ae3.
The provided document describes the safety and effectiveness information for the LEGEND™ Nitrile powder-free patient examination glove. The study demonstrates the device meets acceptance criteria by comparing its performance to established ASTM standards and FDA regulations.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 6319-00ae3 | Meets |
| Palm Width (Small) | 80 +/- 10 mm | 80-90 mm |
| Palm Width (Medium) | 95 +/- 10 mm | 90-100 mm |
| Palm Width (Large) | 110 +/- 10 mm | 100-110 mm |
| Palm Width (X-Large) | 120 +/- 10 mm | 110-120 mm |
| Length (Small) | 220 mm min | 240-250 mm (all sizes) |
| Length (Medium) | 230 mm min | 240-250 mm (all sizes) |
| Length (Large) | 230 mm min | 240-250 mm (all sizes) |
| Length (X-Large) | 230 mm min | 240-250 mm (all sizes) |
| Thickness (Finger) | 0.05 mm min | 0.12 +/- 0.01 mm |
| Thickness (Palm) | 0.05 mm min | 0.12 +/- 0.01 mm |
| Physical Properties | ASTM standard D 6319-00ae3 | Meets |
| Tensile strength (Before aging) | 14 MPa min | 19.0 MPa min |
| Ultimate elongation (Before aging) | 500% min | 630% min |
| Tensile strength (After aging, 22 hours @ 100°C) | 14 MPa min | 19.0 MPa min |
| Ultimate elongation (After aging, 22 hours @ 100°C) | 400% min | 530% min |
| Freedom from pinholes | 21 CFR 800.20 | Meets (Water Tight Test performed to manufacturer's AQL under 21 CFR 820.181) |
| Powder Residual | ASTM standard D 6124-01 | Meets ( |
§ 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.