(92 days)
The 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 vinyl examination gloves. The subject device's color is clear. 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 the device meets the acceptance criteria for Vinyl Examination Gloves. This is a medical device focused on physical properties and biocompatibility, not an AI/imaging device. Therefore, many of the requested criteria regarding AI model evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone algorithm performance, and ground truth establishment methods) are not applicable to this document.
However, I can extract the relevant information regarding the device's performance against its acceptance criteria based on the provided non-clinical testing summary.
Here's the breakdown:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length (mm): S/M/L/XL: ≥230 | |
| Width (mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5 | |||
| Thickness (mm): Finger: ≥0.08; Palm: ≥0.08 | Length (mm): > 230 /Pass | ||
| Width (mm): | |||
| S: 81-88 /Pass | |||
| M: 90-98/ Pass | |||
| L: 100-109/ Pass | |||
| XL:110-118/ Pass | |||
| Thickness (mm): | |||
| Finger: 0.08-0.14/Pass | |||
| Palm: 0.08/Pass | |||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 (AQL 2.5) | 0/125 /Pass (Implies 0 failures out of 125 samples, meeting AQL 2.5) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 |
§ 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.