(78 days)
The vinyl examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The proposed device is a powder free vinyl patient examination glove, provided as nonsterile and disposable device. The proposed device is provided with clear color. There are four sizes: small, medium, large and extra-large as options.
The provided document describes the acceptance criteria and performance data for Vinyl Examination Gloves, a Class I medical device. It does not pertain to an AI/ML-based medical device. Therefore, many of the requested fields regarding AI/ML device testing (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable.
Here's the information extracted from the document, focusing on the device performance and acceptance criteria for these physical examination gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Performance / Results |
|---|---|---|---|
| ASTM D5250 (Physical Dimensions Test) | To verify physical dimensions | - Length: ≥ 230mm |
- Width (Small): 85±5mm
- Width (Medium): 95±5mm
- Width (Large): 105±5mm
- Width (Extra-Large): 115±5mm
- Thickness (Finger): ≥ 0.08mm
- Thickness (Palm): ≥ 0.08mm | Pass |
| ASTM D5250 (Physical Properties - Before Aging) | To determine tensile strength and ultimate elongation before aging | - Tensile Strength: ≥ 11MPa - Ultimate Elongation: ≥ 300% | Pass |
| ASTM D5250 (Physical Properties - After Aging) | To determine tensile strength and ultimate elongation after aging | - Tensile Strength: ≥ 11MPa - Ultimate Elongation: ≥ 300% | Pass |
| ASTM D5151 | Freedom from pinholes | Meets the ASTM D5151 Test for AQL 2.5 requirements | Pass |
| ASTM D6124 | Powder Residue | Meets ASTM D6124 requirements:
§ 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.