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510(k) Data Aggregation
(91 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
This document is a 510(k) premarket notification decision letter from the FDA for several types of nitrile examination gloves. It acknowledges the substantial equivalence of the gloves to legally marketed predicate devices.
The acceptance criteria and device performance are related to the gloves' resistance to permeation by chemotherapy drugs and opioid drugs, specifically Fentanyl Citrate and Xylazine HCl. The study conducted appears to be ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold. Instead, it reports the "Minimum Breakthrough Detection Time in Minutes" for various drugs. For the purpose of this analysis, we can infer that a higher breakthrough time (ideally ">240 minutes") is the desired performance. The document explicitly highlights cases where performance is lower than presumably desired.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) - Acceptance (Inferred) | Pink Gloves Performance | Orange Gloves Performance | Blue Gloves Performance | Black Gloves Performance |
|---|---|---|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | High as possible, ideally >240. (Warning: Do Not Use) | 12.4 | 11.7 | 10.1 | 14.4 |
| Cisplatin (1.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Cytarabine (100 mg/ml) | >240 minutes | >240 | Not tested | >240 | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Etoposide (20.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Fluorouracil (50.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Ifosfamide (50.0 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Methotrexate (25.0 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Mitomycin C (0.5 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Thiotepa (10.0 mg/ml) | High as possible, ideally >240. (Warning: Do Not Use) | 43.1 | 43.2 | 30.2 | 29.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Opioid Drugs | |||||
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Xylazine HCl (100 mg/ml) | >240 minutes | Not Tested | >240 | >240 | >240 |
| Simulated Gastric Acid | >240 minutes | >240 | >240 | >240 | >240 |
Note: For Carmustine (BCNU) and Thiotepa, the warning "Do Not Use with Carmustine (BCNU) and Thiotepa" implies that the reported breakthrough times are considered insufficient for safe use, despite meeting some base level of detection. Thus, the implicit acceptance criterion for these specific drugs is to not use the gloves. For all other drugs where ">240" is reported, this indicates the gloves met or exceeded the 4-hour test duration without breakthrough.
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 or trials) used for the permeation tests. It indicates the testing was "as per ASTM D6978-05 (Reapproved 2019) Standard Practice." This ASTM standard would specify the required sample size and methodology.
The data provenance is not explicitly stated in terms of country of origin but is presented as results from a technical study. This would be a prospective test, as the gloves were submitted for testing to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of testing (chemical permeation) does not typically involve human experts establishing ground truth in the way medical imaging or clinical diagnoses do. The "ground truth" is established by the specified ASTM D6978-05 standard methodology, which is an objective chemical permeation test using analytical equipment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Chemical permeation testing is a laboratory-based, objective measurement, not subject to subjective adjudication by human readers/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:
Not applicable. This is a technical performance test for medical gloves, not a study involving human readers or AI in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth is based on objective chemical permeation measurements performed according to ASTM D6978-05 (Reapproved 2019) Standard Practice. This standard defines the method for detecting the breakthrough of specific chemicals through a material.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable for the same reason as point 8.
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(104 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
I am sorry, but this document is an FDA clearance letter for a medical device (Powder Free Latex Patient Examination Glove), not a study report for a device that utilizes Artificial Intelligence or Machine Learning. Therefore, it does not contain the information required to answer your request regarding acceptance criteria and performance studies for an AI/ML device.
The document discusses regulatory information, indications for use for a glove, and administrative details, but there is no mention of an algorithm, AI, or any associated performance metrics typically found in studies for such devices.
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(131 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
This document describes the acceptance criteria and performance study for the Powder Free Nitrile Patient Examination Glove.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device, particularly for its resistance to chemotherapy drugs and Fentanyl Citrate, are defined by the "Minimum Breakthrough Detection Time in Minutes" as specified in the ASTM D6978-05 (Reapproved 2019) standard. The reported device performance is indicated by the measured breakthrough times against various substances.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection Time in Minutes) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Bendamustine HCI (Treanda) (5 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. A "pass" would typically be >240 minutes for standard chemotherapy glove claims. | >240 |
| Bleomycin Sulfate (15 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Busulfan (6 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Carboplatin (10 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Carfilzomib (2 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Carmustine (BCNU) (3.3 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | 26.2 |
| Cetuximab (Erbitux) (2 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Cisplatin (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Cladribine (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Cyclosporin A (100 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Cytarabine (100 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Cytovene (Ganciclovir) (10 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Dacarbazine (DTIC) (10 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Daunorubicin HCI (5 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Decitabine (5 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Docetaxel (Taxotere) (20 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Doxorubicin Hydrochloride (2 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Epirubicin HCI (Ellence) (2 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Etoposide (20 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Fludarabine (25 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Fluorouracil (50 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Gemcitabine (38 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Idarubicin HCI (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Ifosfamide (50 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Irinotecan (20 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Mechlorethamine HCI (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Melphalan (5 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Methotrexate (25 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Mitomycin C (0.5 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Mitoxantrone (2 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Oxaliplatin (5 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Paclitaxel (Taxol) (6 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Pemetrexed (25 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Raltitrexed (0.5 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Retrovir (Zidovudine) (10 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Rituximab (10 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Thiotepa (10 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | 59.1 |
| Topotecan (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Trisenox (Arsenic Trioxide) (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Velcade (Bortezomib) (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Vidaza (Azacytidine) (25 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Vinblastine (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Vincristine Sulfate (1 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Vinorelbine (10 mg/ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Zoledronic Acid (1 mg/25ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
| Simulated Gastric Acid Fluid | Not explicitly stated as a minimum, but tested to ASTM D6978-05. | >240 |
Note: For Carmustine (BCNU) and Thiotepa, the reported times (26.2 and 59.1 minutes respectively) are below the ">240" observed for most other drugs. This results in explicit warnings not to use with Carmustine (BCNU) and caution when using with Thiotepa due to low permeation times.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of gloves or individual tests) used for the permeation test for each chemical. It only provides the resulting "Minimum Breakthrough Detection Time in Minutes."
The data provenance is not specified in terms of country of origin. The study appears to be a prospective test specifically designed to evaluate the performance of these gloves against the listed chemicals, rather than a retrospective analysis of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (chemical permeation test as per ASTM D6978-05) does not involve human experts establishing "ground truth" in the way that image interpretation or diagnostic studies do. The "ground truth" is the objective measurement of chemical breakthrough time, determined in a laboratory setting according to a standardized protocol (ASTM D6978-05). Therefore, there are no medical experts (e.g., radiologists) involved in establishing this particular ground truth.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is a laboratory-based chemical permeation test, not a subjective assessment requiring adjudication among experts. The results are objective measurements based on the ASTM D6978-05 standard.
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 not a study involving human readers or AI. It is a chemical resistance test for a medical device (gloves).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI study. It is a physical performance test of a medical device.
7. The Type of Ground Truth Used
The ground truth used is objective laboratory measurement based on a standardized protocol, specifically "Assessment of Medical Gloves to Permeation by Chemotherapy Drugs" as per ASTM D6978-05 (Reapproved 2019). The outcome is a quantified "Minimum Breakthrough Detection Time in Minutes."
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study, so there is no concept of 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 physical performance study, no ground truth was established for it.
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