(63 days)
A Nitrile powder free exam glove is a disposable device, worn on the hand or finger to prevent contamination between examiner and patient or victim. This specialty glove has also been tested for use with the Opioid drugs Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid.
Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free. Non-sterile. Ambidextrous. Beaded Cuff. Medical Grade Exam Gloves. Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
This document describes a 510(k) premarket notification for "Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves," which have been "Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)."
Here's an analysis of the acceptance criteria and study information provided:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for these gloves are defined by their resistance to permeation by specific opioid drugs. The performance is reported as the minimum breakthrough time.
| Test Opioid Drug | Concentration | Acceptance Criteria (Minimum Breakthrough Time) | Reported Device Performance (Minimum Breakthrough Time) |
|---|---|---|---|
| Fentanyl citrate (injectable) | (100mcg/2mL) | >240 minutes | >240 minutes |
| Fentanyl citrate (injectable) |
- Heroin | (100mcg/2mL)
- (saturated solution) | >240 minutes | >240 minutes |
| Fentanyl citrate (injectable) - Heroin in Simulated Gastric
Acid Mix | (100mcg/2mL)
Saturated Solution into
simulated Gastric Acid | >240 minutes | >240 minutes |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the specific sample size (e.g., number of gloves tested) or the provenance (country of origin, retrospective/prospective) of the data for these permeation tests. The information is presented as a summary of the test results rather than a detailed study protocol.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the type of device and study being described. The "ground truth" here is established by standardized chemical permeation testing, not by expert interpretation of medical images or clinical data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved. This is a material permeation test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study investigates the impact of AI assistance on human reader performance, which is not relevant for testing the chemical resistance of medical gloves.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This concept is not directly applicable. The "device" in question is a physical glove, not an algorithm. The performance described is inherent to the material properties of the glove itself, measured through chemical testing, which is analogous to a "standalone" performance if we think of the glove's material as the "system" being evaluated. No human interpretation is involved in determining the breakthrough time.
7. The Type of Ground Truth Used
The ground truth used is standardized laboratory chemical permeation testing data. This involves precise measurements of the time it takes for specific concentrations of opioid substances to permeate the glove material under controlled conditions, as opposed to expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. These are medical exam gloves, not an AI or machine learning device requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above; there is no training set for a physical exam glove. The performance criteria are based on established standards for chemical resistance in protective materials.
§ 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.