(148 days)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.
PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
The provided document describes the acceptance criteria and the study that proves Daxwell, LLC's Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) meet those criteria, primarily through a comparison to a predicate device and adherence to established ASTM and ISO standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimension | ASTM D 5250-06(Reapproved 2011) | |
| Length | ≥230mm | 232-240mm |
| Width (Small) | 80-90mm | 81-90mm |
| Width (Medium) | 90-100mm | 93-98mm |
| Width (Large) | 100-110mm | 102-109mm |
| Width (X-Large) | 110-120mm | 110-118mm |
| Thickness (Fingertip) | ≥0.05mm | 0.08-0.11mm |
| Thickness (Palm) | ≥0.08mm | 0.09-0.12mm |
| Physical Properties | ASTM D 5250-06(Reapproved 2011) | |
| Tensile strength (Before & After aging) | ≥11MPa | 15-20MPa |
| Elongated rate (Before & After aging) | ≥300% | 360-420% |
| Freedom from Pinholes | 21 CFR 800.20, ASTM D5250-06 (Reapproved 2011), ASTM D5151-06 (Reapproved 2011), Inspection Level I AQL2.5 | Passed Standard (Waterleak test), Meets ASTM D5151-06 (Reapproved 2011) |
| Powder Residual | ASTM D 5250-06 (Reapproved 2011) and D6124-06 (Reaffirmation 2011) | 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.