(160 days)
A 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.
The proposed device is a disposable device intended for over the counter use. It is not made with natural rubber latex. Instead, the gloves are formulated using vinyl synthetic polymer. The glove is coated with an emollient coating. The gloves are manufactured using molds that are ambidextrous. They are offered powder-free and non-sterile.
The provided document describes the acceptance criteria and performance data for the Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu-Thera® Coating. This is a medical device application for examination gloves, and therefore the "device" in this context refers to these gloves.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Primary Skin Irritation | Non-irritating (per ISO 10993-10) | Non-irritating |
| Guinea Pig Maximization | Non-sensitizing (per ISO 10993-10) | Non-sensitizing |
| Physical Characteristics | ||
| Dimensions | Meets ASTM D5250 requirements | Meets requirements |
| Physical Properties | Meets ASTM D5250 requirements for vinyl examination gloves | Meets requirements |
| Freedom from Holes | Meets 21 CFR 800.20 & ASTM D5250 requirements of AQL 2.5 | Tested in accordance with ASTM D 5151 with acceptable results; Meets requirements of AQL 2.5 |
| Powder Residual | Meets requirements of ≤2.0 mg/glove for "Powder-Free" designation per ASTM D5250 | Gloves meet powder level requirements for "Powder-Free" designation per ASTM D5250. Results generated values |
§ 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.