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510(k) Data Aggregation
(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.
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