(94 days)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue) is a nonsterile 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 Chemotherapy Drugs and Fentanyl Citrate.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) is a nonsterile 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 Chemotherapy Drugs and Fentanyl Citrate.
Not Found
The document describes the "Indications for Use" for two types of Nitrile Powder Free Examination Gloves (Blue and Black), specifically detailing their performance against chemotherapy drugs and Fentanyl Citrate. The study involved testing these gloves according to ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This standard practice is the study that proves the device meets the acceptance criteria.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the test results, which indicate the "Minimum Breakthrough Detection Time in Minutes" for each drug. Generally, a longer breakthrough time is desired. While the document doesn't explicitly state a minimum required breakthrough time as an acceptance criterion for all drugs (except by implication that testing was performed and results are presented), it highlights specific drugs (Carmustine and Thiotepa) with "extremely low permeation times" as a note to the user.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes (Blue Glove) | Minimum Breakthrough Detection Time in Minutes (Black Glove) |
|---|---|---|
| Carmustine (3.3 mg/ml) | 23.3 | 25.0 |
| Cisplatin (1.0 mg/ml) | >240 | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 | >240 |
| Dacarbazine (10.0 mg/ml) | >240 | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 | >240 |
| Etoposide (20.0 mg/ml) | >240 | >240 |
| Fluorouracil (50.0 mg/ml) | >240 | >240 |
| Methotrexate (25.0 mg/ml) | >240 | >240 |
| Mitomycin C (0.5 mg/ml) | >240 | >240 |
| Paclitaxel (6.0 mg/ml) | >240 | >240 |
| Thiotepa (10.0 mg/ml) | 58.2 | 55.7 |
| Vincristine Sulfate (1.0 mg/ml) | >240 | >240 |
| Azacytidine (25.0 mg/ml) | >240 | >240 |
| Carboplatin (10.0 mg/ml) | >240 | >240 |
| Docetaxel (10 mg/ml) | >240 | >240 |
| Epirubicin (2.0 mg/ml) | >240 | >240 |
| Gemcitabine (38 mg/ml) | >240 | >240 |
| Ifosfamide (50 mg/ml) | >240 | >240 |
| Irinotecan (20 mg/ml) | >240 | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 | >240 |
| Oncovin (1.0 mg/ml) | >240 | >240 |
| Oxaliplatin (5 mg/ml) | >240 | >240 |
| Vinorelbine (10 mg/ml) | >240 | >240 |
| Fentanyl Citrate Inj. (100 mcg/2ml) | >240 | >240 |
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 explicitly state the sample size (number of gloves tested) for each drug or the total sample size used in the testing. The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text.
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 a physical product performance test (permeation of gloves by corrosive chemicals), not a diagnostic or AI-assisted interpretation study. Therefore, the concept of "experts establishing ground truth for the test set" and their qualifications does not apply in this context. The "ground truth" is established by the direct measurement of breakthrough time according to the standardized ASTM D6978-05 method.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or expert consensus for labeling data. This is a laboratory test of material properties, so such adjudication methods are not applicable. The results are quantitative measurements.
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
No, an MRMC study was not done. This is a test of a physical device (gloves) against chemical permeation, not a study evaluating human reader performance or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an algorithm or AI performance study, so the concept of standalone performance does not apply.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" in this context is the direct measurement of permeation breakthrough time as determined by the standardized test method ASTM D6978-05 (Reapproved 2013). This is empirical, scientifically derived data from controlled laboratory testing.
8. The sample size for the training set
This is not an AI/machine learning study, so there is no training set. The term "training set" is not applicable here.
9. How the ground truth for the training set was established
Since there is no training set for an AI model, this question is not applicable.
§ 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.