(67 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
| Blue | |
|---|---|
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) |
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine, 3.3 mg/ml | 11.3 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide, 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA, 10.0 mg/ml | 7.4 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 11.3 minutes ThioTEPA (10.0 mg/ml): 7.4 minutes
WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl Citrate:
| Blue | |
|---|---|
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time (minutes) |
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine, 3.3 mg/ml | 30.3 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide, 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA, 10.0 mg/ml | 91.0 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
| Busulfan, 6 mg/ml | > 240 minutes |
| Cytarabine, 100 mg/ml | > 240 minutes |
| Daunorubicin, 5 mg/ml | > 240 minutes |
| Docetaxel, 10 mg/ml | > 240 minutes |
| Epirubicin, 2 mg/ml | > 240 minutes |
| Gemcitabine, 38 mg/ml | > 240 minutes |
| Irinotecan Hydrochloride, 20 mg/ml | > 240 minutes |
| Mechlorethamine HCL, 1.0 mg/ml | > 240 minutes |
| Melphalan, 5 mg/ml | > 240 minutes |
| Trisenox, 0.1 mg/ml | > 240 minutes |
| Fentanyl Citrate, 100mcg/2ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 30.3 minutes ThioTEPA (10.0 mg/ml): 91.0 minutes
CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHERAPY DRUGS
Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue; Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue
This document describes two types of non-sterile, powder-free nitrile examination gloves:
- Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue
- Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue
The acceptance criteria for both devices are primarily based on their resistance to permeation by chemotherapy drugs, as tested according to ASTM D6978 Standard Practice. For the second device, resistance to Fentanyl Citrate is also included.
The study proving the device meets the acceptance criteria is detailed in the "Indications for Use" sections for each glove type.
1. Table of Acceptance Criteria and Reported Device Performance
Device 1: Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, And Tested for use with Chemotherapy Drugs Blue
| Tested Chemotherapy Drug And Concentration | Acceptance Criterion (Minimum Breakthrough Detection Time) | Reported Device Performance (Average Breakthrough Detection Time) |
|---|---|---|
| Carboplatin, 10 mg/ml | Not explicitly stated (implied for medical use performance) | > 240 minutes |
| Carmustine, 3.3 mg/ml | Not explicitly stated | 11.3 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | Not explicitly stated | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | Not explicitly stated | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | Not explicitly stated | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | Not explicitly stated | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | Not explicitly stated | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | Not explicitly stated | > 240 minutes |
| Ifosfamide, 50.0 mg/ml | Not explicitly stated | > 240 minutes |
| Methotrexate, 25 mg/ml | Not explicitly stated | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | Not explicitly stated | > 240 minutes |
| Mitoxantrone, 2 mg/ml | Not explicitly stated | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | Not explicitly stated | > 240 minutes |
| ThioTEPA, 10.0 mg/ml | Not explicitly stated | 7.4 minutes |
| Vincristine Sulfate, 1.0 mg/ml | Not explicitly stated | > 240 minutes |
Note: The document explicitly warns: "WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA" due to their extremely low permeation times (11.3 minutes and 7.4 minutes, respectively). This implicitly sets an acceptance criterion that usage with these drugs is not recommended, rather than a performance threshold for them. For other drugs, a permeation time of "> 240 minutes" appears to be the target performance for safe use.
Device 2: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate - Blue
| Tested Chemotherapy Drug And Concentration | Acceptance Criterion (Minimum Breakthrough Detection Time) | Reported Device Performance (Average Breakthrough Detection Time) |
|---|---|---|
| Carboplatin, 10 mg/ml | Not explicitly stated (implied for medical use performance) | > 240 minutes |
| Carmustine, 3.3 mg/ml | Not explicitly stated | 30.3 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | Not explicitly stated | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | Not explicitly stated | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | Not explicitly stated | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | Not explicitly stated | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | Not explicitly stated | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | Not explicitly stated | > 240 minutes |
| Ifosfamide, 50.0 mg/ml | Not explicitly stated | > 240 minutes |
| Methotrexate, 25 mg/ml | Not explicitly stated | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | Not explicitly stated | > 240 minutes |
| Mitoxantrone, 2 mg/ml | Not explicitly stated | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | Not explicitly stated | > 240 minutes |
| ThioTEPA, 10.0 mg/ml | Not explicitly stated | 91.0 minutes |
| Vincristine Sulfate, 1.0 mg/ml | Not explicitly stated | > 240 minutes |
| Busulfan, 6 mg/ml | Not explicitly stated | > 240 minutes |
| Cytarabine, 100 mg/ml | Not explicitly stated | > 240 minutes |
| Daunorubicin, 5 mg/ml | Not explicitly stated | > 240 minutes |
| Docetaxel, 10 mg/ml | Not explicitly stated | > 240 minutes |
| Epirubicin, 2 mg/ml | Not explicitly stated | > 240 minutes |
| Gemcitabine, 38 mg/ml | Not explicitly stated | > 240 minutes |
| Irinotecan Hydrochloride, 20 mg/ml | Not explicitly stated | > 240 minutes |
| Mechlorethamine HCL, 1.0 mg/ml | Not explicitly stated | > 240 minutes |
| Melphalan, 5 mg/ml | Not explicitly stated | > 240 minutes |
| Trisenox, 0.1 mg/ml | Not explicitly stated | > 240 minutes |
| Fentanyl Citrate, 100mcg/2ml | Not explicitly stated | > 240 minutes |
Note: The document states: "CAUTION: CARMUSTINE (3.3 MG/ML) AND THIOTEPA (10 MG/ML) HAVE MUCH LOWER PERMEATION TIMES COMPARE TO OTHER CHEMOTHERAPY DRUGS". Similar to Device 1, this indicates that while tested, their permeation times (30.3 minutes and 91.0 minutes, respectively) are lower than the target for other drugs, suggesting a cautionary use or implicit lower acceptance for these specific substances.
2. Sample size used for the test set and the data provenance
The document specifies that the gloves were "tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."
- Sample Size for the Test Set: The document does not explicitly state the sample size (e.g., number of gloves or tests performed per drug) used for these tests. The ASTM D6978 standard would likely specify the required number of replicates.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. The testing was conducted by YTY Industry (Manjung) Sdn Bhd, located in Malaysia, suggesting the tests were performed in Malaysia. The nature of laboratory testing like this is inherently prospective for the specific batch or design of gloves being evaluated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this document. The "ground truth" here is the physical measurement of chemical permeation, determined by laboratory testing methods described in ASTM D6978, rather than expert interpretation of medical images or diagnostic data. There is no indication of experts being used to establish a ground truth for the test results.
4. Adjudication method for the test set
This question is not applicable. The test results are objective chemical permeation measurements (breakthrough detection time), not subjective interpretations that require adjudication by experts.
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
This question is not applicable. The device is a medical glove, not an AI-powered diagnostic tool requiring human interpretation or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a medical glove, not an algorithm. The performance described is that of the physical product itself.
7. The type of ground truth used
The ground truth used is laboratory measurement of chemical permeation according to the ASTM D6978 standard. This standard describes methods to evaluate the resistance of medical gloves to permeation by chemotherapy drugs, typically by detecting the breakthrough of a specific chemical through the glove material over time.
8. The sample size for the training set
This question is not applicable. The device consists of physical gloves, not a machine learning model, and therefore does not have a "training set" in the computational sense. The manufacturing process of gloves might involve quality control and material testing, but this is distinct from training a dataset for an algorithm.
9. How the ground truth for the training set was established
This question is not applicable, as there is no "training set" for this physical device.
§ 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.