(59 days)
A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested for use with Chemotherapy Drugs and the Opioid Fentanyl citrate, simulated Gastric Acid and Fentanyl in Gastric Acid.
Powder Free Nitrile Examination Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)
The provided text describes the indications for use and performance of Powder Free Nitrile Examination Gloves, specifically tested for chemotherapy drugs and fentanyl. This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study report that would typically detail acceptance criteria and a study design for a new device's performance.
Therefore, the information required to fully answer your request regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not present in this document. This document primarily presents the results of testing the gloves against various substances.
However, I can extract the reported device performance from the provided tables, which can be interpreted as demonstrating that the device met certain performance criteria for breakthrough detection times. The implicit acceptance criterion for most of the listed substances appears to be "no breakthrough up to 240 minutes."
Here's a breakdown based on the available information:
1. Table of acceptance criteria and the reported device performance
| Chemo/Opioid Drug | Concentration Tested | Implicit Acceptance Criterion (Maximum Breakthrough Detection Time) | Reported Device Performance (Minimum Breakthrough Detection Time) |
|---|---|---|---|
| Carboplatin | 10.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Carmustine (BCNU) | 3.3mg/ml | Not met (Explicit warning provided) | 23.6 minutes |
| Cisplatin | 10.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Cytarabine HCL | 100.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Dacarbazine (DTIC) | 10.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Docetaxel | 10.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Doxorubicin Hydrochloride | 2.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Etoposide (Toposar) | 20.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Fluorouracil | 50.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Gemcitabine | 38.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Ifosfamide | 50.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Irinotecan | 20.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Mechlorethamine | 1.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Melphalan | 5.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Methotrexate | 25.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Mitomycin C | 0.5mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Mitoxantrone | 2.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Paclitaxel (Taxol) | 6.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| ThioTepa | 10.0mg/ml | Not met (Explicit warning provided) | 57.8 minutes |
| Vincristine Sulfate | 1.0mg/ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Fentanyl citrate (injectable) | 100mg/2ml | >= 240 minutes | No breakthrough up to 240 minutes |
| Gastric Acid (simulated) | 0.2%NaCl in 0.7 HCL | >= 240 minutes | No breakthrough up to 240 minutes |
| Fentanyl in Gastric Acid | 50/50 mix | >= 240 minutes | No breakthrough up to 240 minutes |
Note: The acceptance criterion of "No breakthrough up to 240 minutes" is inferred from the reported performance for most substances. For Carmustine and ThioTepa, the low breakthrough times are explicitly called out as a warning, indicating they do not meet the implied 240-minute resistance for other drugs/substances.
The following information is NOT available in the provided document:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document does not specify the number of gloves tested for each substance or the origin/type of data collection. This is typical for a 510(k) summary, which often references testing standards (e.g., ASTM standards for glove permeability) rather than detailing the full study protocol.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A, as this is a physical barrier test, not an assessment requiring expert interpretation of complex data (like medical imaging). The "ground truth" would be the chemical breakthrough itself, detected by analytical methods.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A. This is not an AI or diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this type of device, the "ground truth" is the objective measurement of chemical breakthrough time, typically determined by standardized laboratory methods (e.g., in accordance with ASTM D6978 for chemotherapy drugs).
- The sample size for the training set: N/A. There is no AI or machine learning component that would require a training set.
- How the ground truth for the training set was established: N/A.
§ 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.