(9 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 non-colored vinyl examination glove. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.
The provided text describes the acceptance criteria and the study that proves a "Disposable Vinyl Examination Glove" meets these criteria. It is important to note that this is a Class I medical device (non-AI/ML).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length: S/M/L/XL: ≥230mm | |
| Width: S: 85±5mm; M: 95±5mm; L: 105±5mm; XL: 115±5mm | |||
| Thickness: Finger: ≥0.08mm; Palm: ≥0.08mm | Length: >230mm / Pass | ||
| Width: S: 84-87mm / Pass; M: 92-96mm / Pass; L: 103-106mm / Pass; XL: 112-117mm / Pass | |||
| Thickness: Finger: 0.13-0.15mm / Pass; Palm: 0.09-0.12mm / Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | AQL 2.5 | 0/125 / Pass |
| ASTM D6124 | Powder Content |
§ 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.