(51 days)
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotheraty Drugs and Fentany Citrate (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Cliemotherapy Drugs and Fentanyl Citrate
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
This document is a 510(k) clearance letter for "Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)". It details the device's indications for use and performance related to permeation by chemotherapy drugs and Fentanyl Citrate.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by the standard ASTM D6978-05 (Reapproved 2013) and the reported minimum breakthrough detection times for various chemotherapy drugs and Fentanyl Citrate. The goal is to demonstrate that the gloves provide a protective barrier for a sufficient duration. The reported performance refers to the breakthrough times achieved during testing.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Implied by standard and intended use) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (3.3 mg/ml) | Protection against permeation | 21.4 |
| Cisplatin (1.0 mg/ml) | Protection against permeation | >240 |
| Cyclophosphamide (20.0 mg/ml) | Protection against permeation | >240 |
| Dacarbazine (10.0 mg/ml) | Protection against permeation | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Protection against permeation | >240 |
| Etoposide (20.0 mg/ml) | Protection against permeation | >240 |
| Fluorouracil (50.0 mg/ml) | Protection against permeation | >240 |
| Methotrexate (25.0 mg/ml) | Protection against permeation | >240 |
| Mitomycin C (0.5 mg/ml) | Protection against permeation | >240 |
| Paclitaxel (6.0 mg/ml) | Protection against permeation | >240 |
| Thiotepa (10.0 mg/ml) | Protection against permeation | 67.2 |
| Vincristine Sulfate (1.0 mg/ml) | Protection against permeation | >240 |
| Azacytidine (25.0 mg/ml) | Protection against permeation | >240 |
| Carboplatin (10.0 mg/ml) | Protection against permeation | >240 |
| Docetaxel (10 mg/ml) | Protection against permeation | >240 |
| Epirubicin (2.0 mg/ml) | Protection against permeation | >240 |
| Gemcitabine (38 mg/ml) | Protection against permeation | >240 |
| Ifosfamide (50 mg/ml) | Protection against permeation | >240 |
| Irinotecan (20 mg/ml) | Protection against permeation | >240 |
| Mitoxantrone (2.0 mg/ml) | Protection against permeation | >240 |
| Oncovin (1.0 mg/ml) | Protection against permeation | >240 |
| Oxaliplatin (5 mg/ml) | Protection against permeation | >240 |
| Vinorelbine (10 mg/ml) | Protection against permeation | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | Protection against permeation | >240 |
Note: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of 21.4 minutes and 67.2 minutes respectively. Warning: Do not use with Carmustine". This implies that while the device was tested against Carmustine, its low breakthrough time means it does not meet a practical "acceptance" for safe use with that particular drug, leading to a specific warning. For other drugs, a breakthrough time of >240 minutes indicates good performance.
2. Sample size 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 sample size used for the test set (number of gloves or repetitions per drug). It also does not explicitly state the data provenance or whether the study was retrospective or prospective. The testing was conducted "as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs," which is a standardized testing method.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device and study. The "ground truth" here is the physical permeation of chemicals through the glove material, measured in a laboratory setting using analytical techniques as defined by the ASTM standard. It does not involve expert interpretation or consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This study involves objective laboratory measurements, not subjective evaluations requiring adjudication.
5. 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
Not applicable. This is a study on the barrier effectiveness of gloves against chemical permeation, not an AI-assisted diagnostic study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes a physical performance test of a medical device (gloves), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is the empirically measured breakthrough time of various chemotherapy drugs and Fentanyl Citrate through the glove material, determined according to the methodologies outlined in ASTM D6978-05. This is a direct physical measurement.
8. The sample size for the training set
Not applicable. This refers to the testing of a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device testing.
§ 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.