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510(k) Data Aggregation
(91 days)
Kossan International Sdn Bhd
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.
Ask a specific question about this device
(104 days)
Kossan International Sdn Bhd
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.
Ask a specific question about this device
(131 days)
Kossan International Sdn Bhd3
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.
Ask a specific question about this device
(75 days)
Kossan International Sdn. Bhd.
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.
Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim; Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim
The provided text is an FDA 510(k) clearance letter for a medical device: "Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim" and "Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim."
This document grants substantial equivalence based on the device's intended use as a patient examination glove, which is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner."
The FDA letter does not include information about AI/ML device performance, acceptance criteria, test set details, expert ground truth establishment, MRMC studies, or any of the other specific questions related to AI/ML device validation. These are standard requirements for AI/ML-driven medical devices, but this document pertains to a Class I medical device (gloves), which typically undergo different types of evaluation (e.g., biocompatibility, physical properties, sterility, and non-pyrogenicity) rather than AI/ML performance studies.
Therefore, it is not possible to extract the requested information from the provided text, as it describes the regulatory clearance for examination gloves, not an AI/ML powered device.
Ask a specific question about this device
(81 days)
Kossan International Sdn. Bhd.
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 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
This document describes the acceptance criteria and the study results for Kossan International Sdn. Bhd.'s Powder Free Nitrile Patient Examination Gloves.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the gloves are based on their resistance to permeation by chemotherapy drugs and Fentanyl Citrate, as determined by ASTM D6978-05 (Reapproved 2013). The reported device performance is the "Minimum Breakthrough Detection Time in Minutes" for each substance.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection Time in Minutes) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | (Not explicitly defined, but a longer time is better) | 25.2 |
| Cisplatin (1.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Cytarabine (100 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Etoposide (20.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Fluorouracil (50.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Ifosfamide (50.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Methotrexate (25.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Mitomycin C (0.5 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Mitoxantrone (2.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Thiotepa (10.0 mg/ml) | (Not explicitly defined, but a longer time is better) | 35.9 |
| Vincristine Sulfate (1.0 mg/ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | (Not explicitly defined, but a longer time is better) | >240 |
| Simulated Gastric Acid Fluid | (Not explicitly defined, but a longer time is better) | >240 |
Note: While specific numerical "acceptance criteria" are not explicitly stated as pass/fail thresholds in the document for each drug, the implication of conducting the test and reporting breakthrough times is that these values met the manufacturer's internal standards and/or the expectations for substantial equivalence based on the ASTM D6978-05 standard. The goal is to maximize the breakthrough time for safety.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size (number of gloves or trials) used for the permeation tests. It only states that the gloves "were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." Following an ASTM standard typically implies a specific number of replicates, but this detail is not provided.
The data provenance is from prospective testing conducted by the manufacturer according to the specified ASTM standard. The country of origin of the data is not explicitly stated, but the manufacturer, Kossan International Sdn. Bhd., is based in Malaysia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of device and study. The "ground truth" for glove permeation is established by objective laboratory measurements using analytical techniques to detect the breakthrough of chemical substances, not by expert interpretation.
4. Adjudication method for the test set
This is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints. For a technical performance test like chemical permeation, the results are objective 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
This is not applicable. This document pertains to the performance of examination gloves against chemical permeation, not a diagnostic device involving human readers or AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This document pertains to the performance of examination gloves against chemical permeation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is objective laboratory measurement (detection of chemical permeation through the glove material) based on the methodology outlined in ASTM D6978-05.
8. The sample size for the training set
This is not applicable. The device is a physical product (gloves) and does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above (physical product, no training set).
Ask a specific question about this device
(130 days)
Kossan International Sdn. Bhd.
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 per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Not Found
Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Patient Examination Gloves, based on the provided document:
Acceptance Criteria and Reported Device Performance
The device, Powder Free Nitrile Patient Examination Gloves (Blue, White, and Black Colored), was tested for permeation by chemotherapy drugs and Fentanyl Citrate according to ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The acceptance criteria are implied to be the reported "Minimum Breakthrough Detection Time in Minutes" for each drug, which the device performance meets or exceeds.
Device Performance Tables:
1. Blue Colored Gloves:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 10.1 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 30.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Note: Carmustine (BCNU) has an extremely low permeation time of 10.1 minutes.
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
2. White Colored Gloves:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 10.1 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 10.4 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Note: Carmustine (BCNU) and Thiotepa have extremely low permeation times: 10.1 minutes and 10.4 minutes, respectively.
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
3. Black Colored Gloves:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 14.4 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 29.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Note: Carmustine (BCNU) and Thiotepa have extremely low permeation times: 14.4 minutes and 29.2 minutes, respectively.
| Fentanyl Citrate and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Study Information:
2. Sample size used for the test set and the data provenance:
- The document implies that the "test set" consists of multiple samples of each glove type (Blue, White, Black) that were subjected to testing against the listed chemotherapy drugs and Fentanyl Citrate.
- The exact sample size (number of gloves or individual tests) is not explicitly stated in the provided text.
- The data provenance is not definitively stated, but it is a premarket notification (510(k)) from a Malaysian company (Kossan International Sdn. Bhd.). It is implied that the testing was conducted to support this submission, likely by or for the manufacturer. The data is retrospective in relation to the submission date.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the study involves laboratory testing for chemical permeation, not clinical performance or image interpretation requiring expert opinion. The "ground truth" is established by the direct measurement of chemical breakthrough time following the ASTM D6978-05 standard.
4. Adjudication method for the test set:
- This information is not applicable for a laboratory chemical permeation test. The results are quantitative measurements obtained through instrument analysis.
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 is not applicable as the device is a patient examination glove, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical medical glove and does not involve an algorithm. The testing described is for the barrier properties of the glove material.
7. The type of ground truth used:
- The ground truth is based on direct laboratory measurement of chemical permeation/breakthrough time, as defined by the ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
8. The sample size for the training set:
- This is not applicable as the study does not involve an algorithm or machine learning that requires a training set. The data presented is the result of direct physical and chemical property testing.
9. How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of device and study.
Ask a specific question about this device
(132 days)
Kossan International Sdn. Bhd.
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 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 26.2 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine(100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 59.1 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 26.2 and 59.1 minutes respectively.
Fentanyl Citrate and Concentration Fentanyl Citrate Injection (100 mcg/2ml) Minimum Breakthrough Detection Time in Minutes >240
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
This document is a 510(k) Premarket Notification from the FDA for a medical device: "Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate."
It describes the Indications for Use and provides test results related to its performance with chemotherapy drugs and Fentanyl Citrate. However, it does not include information about AI/algorithm performance, ground truth establishment, expert review, or sample sizes related to AI studies. Therefore, many of the requested categories cannot be populated from the provided text.
Here is the information that can be extracted or deduced from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for glove performance against permeation by chemotherapy drugs and Fentanyl Citrate are implied by the standard used (ASTM D6978-05 (Reapproved 2013)) and the reporting of "Minimum Breakthrough Detection Time in Minutes." While an explicit numeric acceptance threshold isn't stated as "acceptance criteria" in the table heading, the values themselves represent the device's performance against relevant standards.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 26.2 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 59.1 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
Note: The document explicitly states: "Please note that Carmustine (BCNU) and Thiotepa has low permeation times of 26.2 and 59.1 minutes respectively." This highlights these drugs as having lower breakthrough times compared to others.
Information Not Available in the Provided Text:
The following information cannot be extracted from the provided FDA 510(k) document because it pertains to the evaluation of an Artificial Intelligence (AI) or algorithm-based device, whereas this document describes a physical medical device (examination gloves).
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this is a physical medical device, not an AI/algorithm. The "test set" would refer to the gloves tested against various chemicals, but detailed sample sizes for the chemical permeation tests are not provided beyond the results themselves.
- 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): Not applicable for a physical medical device. Ground truth for chemical permeation is typically established by instrumental analysis according to a standard.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a physical medical device.
- 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, as this is a physical medical device, not an AI/algorithm designed to assist human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI/algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the glove's performance, the ground truth is established by the standardized testing methodology (ASTM D6978-05) involving chemical permeation measurements. This is an objective, laboratory-based physical test rather than a clinical ground truth like pathology or expert consensus.
- The sample size for the training set: Not applicable, as this is a physical medical device, not an AI/algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable, as this is a physical medical device, not an AI/algorithm.
Ask a specific question about this device
(151 days)
Kossan International Sdn. Bhd.
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 per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs
The provided text is a 510(k) premarket notification for patient examination gloves, specifically focusing on their resistance to chemotherapy drugs. The study described is a chemical permeation test, not a study involving AI, human readers, or medical imaging. Therefore, many of the requested criteria (like ground truth establishment with experts, MRMC studies, or training set details) are not applicable to this type of device and study.
However, I can extract the acceptance criteria and the device's performance based on the provided tables.
Acceptance Criteria and Device Performance for Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs (K170397)
The acceptance criterion for these gloves regarding chemotherapy drug permeation is established by the ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The "Minimum Breakthrough Detection Time" listed in the table represents the device's performance against each specified drug. Implicitly, for the device to be considered acceptable, the breakthrough time must meet or exceed a certain, unstated, threshold relative to the expected duration of risk or exposure. For most drugs, a breakthrough time of ">240 minutes" indicates high resistance. However, the manufacturer notes that Carmustine (BCNU) and Thiotepa show significantly lower breakthrough times, indicating they are aware of and disclosing these specific limitations against their acceptance criteria.
Table of Acceptance Criteria and Reported Device Performance (Blue Colored Glove)
| Chemotherapy Drug and Concentration | Acceptance Criteria (Based on ASTM D6978-05 standard, generally aiming for high resistance) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | Defined by ASTM D6978-05, no specific numerical threshold provided here for individual drugs beyond the general standard. | 10.2 |
| Cisplatin (1.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Cytarabine (100 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Etoposide (20.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Fluorouracil (50.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Ifosfamide (50.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Methotrexate (25.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Mitomycin C (0.5 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Mitoxantrone (2.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Thiotepa (10.0 mg/ml) | Defined by ASTM D6978-05 | 30.4 |
| Vincristine Sulfate (1.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
Acceptance Criteria and Device Performance for Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs (K170397)
The acceptance criterion for these gloves is identical, based on ASTM D6978-05 (Reapproved 2013).
Table of Acceptance Criteria and Reported Device Performance (White Colored Glove)
| Chemotherapy Drug and Concentration | Acceptance Criteria (Based on ASTM D6978-05 standard, generally aiming for high resistance) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | Defined by ASTM D6978-05 | 10.1 |
| Cisplatin (1.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Cytarabine (100 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Etoposide (20.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Fluorouracil (50.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Ifosfamide (50.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Methotrexate (25.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Mitomycin C (0.5 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Mitoxantrone (2.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
| Thiotepa (10.0 mg/ml) | Defined by ASTM D6978-05 | 30.4 |
| Vincristine Sulfate (1.0 mg/ml) | Defined by ASTM D6978-05 | >240 |
Since this is a report for medical gloves and not an AI/imaging device, the following points are not applicable (N/A) based on the provided text:
- Sample size used for the test set and the data provenance: The document does not specify the number of gloves tested for each drug, only the minimum breakthrough detection time. Data provenance refers to the origin of the materials or testing, which would presumably be the manufacturer's testing facilities (Kossan International Sdn. Bhd. in Malaysia). This is a measurement of physical properties.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth for chemical permeation is established by direct measurement using specified laboratory methods (ASTM D6978-05). It does not require human expert consensus or interpretation in the way AI or imaging studies do.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A. Adjudication is for human interpretation of data, not physical property testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: N/A. This is a framework for comparing human reader performance, typically with and without AI assistance in medical imaging.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. The device is a physical glove, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is the measured breakthrough time as determined by the ASTM D6978-05 standard, which describes the specific laboratory methodology to assess permeation.
- The sample size for the training set: N/A. There is no concept of a "training set" for physical product testing via a standardized method like ASTM D6978-05.
- How the ground truth for the training set was established: N/A.
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(401 days)
KOSSAN INTERNATIONAL SDN. BHD.
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 as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs; and Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs, is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The gloves are made of Nitrile Butadiene Rubber, powder free, ambidextrous with beaded-cuff, blue or white colored, single-use disposable devices that come in six sizes (XS, S, M, L, XL, XXL), and supplied in Non-Sterile state. These gloves were designed and manufactured per ASTM D6319-10 standard, and tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The provided document describes the acceptance criteria and performance data for two types of Powder Free Nitrile Patient Examination Gloves (blue and white colored) tested for use with chemotherapy drugs.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are established by various ASTM standards. The reported device performance is presented as a "Results Summary" or direct values.
| Characteristic | Standard Requirements | Reported Device Performance (Summary / Blue Glove) | Reported Device Performance (Summary / White Glove) |
|---|---|---|---|
| Dimensions | ASTM D6319-10: Length ≥ 230mm, Palm Thickness ≥ 0.05mm, Finger Thickness ≥ 0.05mm, Widths for XS-XXL | Meets Standard Requirements (Specific ranges for Length, Palm/Finger Thickness, and Width are provided in the source for each size, all falling within or exceeding the standard requirements) | Meets Standard Requirements (Specific ranges for Length, Palm/Finger Thickness, and Width are provided in the source for each size, all falling within or exceeding the standard requirements) |
| Physical Properties | ASTM D6319-10: Before Aging: Tensile Strength ≥ 14 MPA, Elongation ≥ 500%; After Aging: Tensile Strength ≥ 14 MPA, Elongation ≥ 400% | Meets Standard Requirements (Table states values met) | Meets Standard Requirements (Table states values met) |
| Freedom from Pinholes | ASTM D5151-11, ASTM D6319-10: Pass quality level at G1 AQL 1.5 | Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5. | Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5. |
| Powder Free Residue | ASTM D6124-11, ASTM D6319-10: ≤ 2 mg of residual powder per glove | Result generated values ≤ 2 mg of residual powder per glove. | Result generated values ≤ 2 mg of residual powder per glove. |
| Biocompatibility | Dermal Sensitization (ISO 10993-10:2010), Primary Skin Irritation Test (ISO 10993-10:2010) | Magnusson & Kligman Scale is '0' (not a sensitizer). Primary Irritation Index for Erythema and Edema is '0' (not an irritant). | Magnusson & Kligman Scale is '0' (not a sensitizer). Primary Irritation Index for Erythema and Edema is '0' (not an irritant). |
| Chemotherapy Drugs Permeation Test (ASTM D6978-05) | No explicit general "acceptance criteria" is listed beyond the standard itself. Performance is measured by Minimum Breakthrough Detection Time. | Carmustine (BCNU) (3.3 mg/ml): 10.1 min | |
| Cisplatin (1.0 mg/ml): >240 min | |||
| Cyclophosphamide (Cytoxan) (20.0 mg/ml): >240 min | |||
| Cytarabine (100 mg/ml): >240 min | |||
| Dacarbazine (DTIC) (10.0 mg/ml): >240 min | |||
| Doxorubicin Hydrochloride (2.0 mg/ml): >240 min | |||
| Etoposide (20.0 mg/ml): >240 min | |||
| Fluorouracil (50.0 mg/ml): >240 min | |||
| Ifosfamide (50.0 mg/ml): >240 min | |||
| Methotrexate (25.0 mg/ml): >240 min | |||
| Mitomycin C (0.5 mg/ml): >240 min | |||
| Mitoxantrone (2.0 mg/ml): >240 min | |||
| Paclitaxel (Taxol) (6.0 mg/ml): >240 min | |||
| Thiotepa (10.0 mg/ml): 30.2 min | |||
| Vincristine Sulfate (1.0 mg/ml): >240 min | Carmustine (BCNU) (3.3 mg/ml): 10.1 min | ||
| Cisplatin (1.0 mg/ml): >240 min | |||
| Cyclophosphamide (Cytoxan) (20.0 mg/ml): >240 min | |||
| Cytarabine (100 mg/ml): >240 min | |||
| Dacarbazine (DTIC) (1.0 mg/ml): >240 min | |||
| Doxorubicin Hydrochloride (2.0 mg/ml): >240 min | |||
| Etoposide (20.0 mg/ml): >240 min | |||
| Fluorouracil (50.0 mg/ml): >240 min | |||
| Ifosfamide (50.0 mg/ml): >240 min | |||
| Methotrexate (25.0 mg/ml): >240 min | |||
| Mitomycin C (0.5 mg/ml): >240 min | |||
| Mitoxantrone (2.0 mg/ml): >240 min | |||
| Paclitaxel (Taxol) (6.0 mg/ml): >240 min | |||
| Thiotepa (10.0 mg/ml): 10.4 min | |||
| Vincristine Sulfate (1.0 mg/ml): >240 min |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document extensively refers to testing according to specific ASTM and ISO standards for various characteristics. While these standards implicitly define sample sizes and testing methodologies, the exact sample sizes used for each specific test (e.g., number of gloves for pinhole test, number of samples for chemotherapy drug permeation) are not explicitly stated in the provided text.
- Data Provenance: The manufacturer is Kossan International Sdn. Bhd., located in Malaysia. It is highly probable the testing and data originate from Malaysia or laboratories contracted by the Malaysian manufacturer. The data appears to be prospective as it involves the performance testing of new devices against established standards prior to market approval.
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 question is not applicable to this type of device and study. The "ground truth" here is not established by human experts interpreting data. Instead, it is defined by objective, quantifiable physical and chemical properties measured according to standardized methods (ASTM, ISO). For example, the breakthrough time for chemotherapy drugs is a direct measurement, not an expert assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert consensus processes for ambiguous cases in diagnostic studies. The performance testing for these gloves relies on direct, objective measurements against pre-defined physical and chemical standards, not on subjective interpretations 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
This question is not applicable. This document describes the performance of a patient examination glove, a physical medical device. It does not involve any imaging, diagnostic algorithms, or human reader interpretation, nor does it concern AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. As stated above, this is a physical medical device (gloves) and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the objective performance metrics and thresholds established by recognized national and international standards. For example:
- ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-11 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-11 (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D6978-05 (Reapproved 2013) (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
- ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
The "ground truth" is therefore based on standardized test methods and predetermined quantitative criteria.
8. The sample size for the training set
This question is not applicable. This device is a physical product and does not involve AI/ML models that require a "training set." The testing described evaluates the manufactured product's inherent physical and chemical properties.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
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(165 days)
Kossan International Sdn. Bhd.
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 per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
This document is a 510(k) premarket notification from the FDA regarding "Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim."
The document does not describe the acceptance criteria and a study for an AI-powered device. Instead, it outlines the performance of medical gloves against chemotherapy drug permeation. Therefore, most of the requested information regarding AI device studies cannot be extracted.
However, I can provide the acceptance criteria and reported device performance related to chemotherapy drug permeation for the gloves as presented in the document.
1. A table of acceptance criteria and the reported device performance
For the specific context of these gloves and chemotherapy drug permeation, the "acceptance criteria" appear to be implied by the minimum breakthrough detection times. The device's performance is the reported breakthrough time for each drug.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection Time) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | N/A (Tested per ASTM D6978-05) | 30.1 |
| Cisplatin (1.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Cytarabine (100 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Etoposide (20.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Fluorouracil (50.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Ifosfamide (50.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Methotrexate (25 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Mitomycin C (0.5 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Mitoxantrone (2.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
| Thiotepa (10.0 mg/ml) | N/A (Tested per ASTM D6978-05) | 50.5 |
| Vincristine Sulfate (1.0 mg/ml) | N/A (Tested per ASTM D6978-05) | >240 |
Note: The phrase "minimum breakthrough detection time" in the table heading implies these are the observed times. The standard ASTM D6978-05 would define the methodology and potential performance requirements, but the document itself doesn't explicitly state a pass/fail threshold for these times. However, the subsequent note highlights drugs with "extremely low permeation times of less than 60 minutes," suggesting a 60-minute threshold might be implicitly relevant for practical use considerations.
The document does not provide information for the following points as they are typically relevant for AI/software-as-a-medical-device (SaMD) studies, not for the physical examination gloves described:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method
- If a multi reader multi case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
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