(161 days)
This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination. These Gloves are tested for use with Chemotherapy Drugs DO NOT USE with Carmustine or Thiotepa.
This surgeon's glove is a device made of Flexylon.
This document is a 510(k) premarket notification for Finessis Zero Flexylon Powder Free Sterile White Surgical Gloves, tested for use with chemotherapy drugs. It is a Class I device, regulated under 21 CFR 878.4460 (Surgeon's Glove), with product codes KGO and LZC.
The study presented focuses specifically on the glove's resistance to breakthrough by various chemotherapy drugs, as tested according to ASTM D6978-05.
Here's an analysis of the provided information, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a general sense within the document, but the performance is presented as the breakthrough detection time for each chemotherapy drug. The implicit acceptance criterion for a glove "tested for use with chemotherapy drugs" is that it should demonstrate a reasonable and safe resistance to permeation by these cytotoxic agents. For most drugs, the goal is "No Breakthrough up to 240 min."
| Tested Chemotherapy Drug and Concentration per ASTM D6978-05 | Acceptance Criteria (Implicit) | Reported Device Performance (Minimum Breakthrough Detection (Specimen 1/2/3) (Minutes)) | Meets/Does Not Meet (Relative to 240 min goal) |
|---|---|---|---|
| Drugs with Breakthrough: | > 240 min (ideal) | ||
| 1 Carmustine (BCNU), 3.3mg/ml (3,300 ppm) | > 240 min (ideal, but a specific threshold for "safety" is not given) | 6.9 (9.0, 12.3, 6.9) | Does Not Meet |
| 12 Thiotepa, 10.0 mg/ml (10,000 ppm) | > 240 min (ideal, but a specific threshold for "safety" is not given) | 7.6 (9.2, 7.6, 10.0) | Does Not Meet |
| Drugs with No Breakthrough: | No Breakthrough up to 240 min | ||
| 2 Cisplatin, 1.0 mg/ml (1,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 3 Cyclophosphamide (Cytoxan), 20 mg/ml (20,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 4 Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 5 Doxorubicin Hydrochloride, 2.0mg/ml (2,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 6 Etoposide (Toposar), 20.0 mg/ml (20,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 7 Fluorouracil, 50.0 mg/ml (50,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 8 Ifosfamide, 50.0 mg/ml (50,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 9 Methotrexate, 25 mg/ml (25,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 10 Mitomycin C, 0.5 mg/ml (500 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 11 Paclitaxel (Taxol), 6.0 mg/ml (6,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 13 Vincristine Sulfate, 1.0 mg/ml (1,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 14 Bleomycin, 15 mg/ml (15,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 15 Busulfan, 6 mg/ml (6,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 16 Carboplatin, 10 mg/ml (10,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 17 Cytarabine, 100 mg/ml (100,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 18 Daunorubicin, 5 mg/ml (5,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 19 Docetaxel, 10.0 mg/ml (10,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 20 Epirubicin, 2.0 mg/ml (2,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 21 Fludarabine, 25 mg/ml (25,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 22 Ganciclovir, 10 mg/ml (10,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 23 Gemcitabine (Gemzar), 38 mg/ml (38,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 24 Idarubicin, 1.0 mg/ml (1,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 25 Irinotecan, 20.0 mg/ml (20,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 26 Mechlorethamine HCI, 1.0 mg/ml (1,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 27 Melphalan, 5.0 mg/ml (5,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 28 Mitoxantrone, 2.0 mg/ml (2,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 29 Oxaliplatin, 2.0 mg/ml (2,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 30 Rituximab, 10 mg/ml (10,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 31 Trisenox, 0.1 mg/ml (100 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
| 32 Vinorelbine, 10 mg/ml (10,000 ppm) | No Breakthrough up to 240 min | No Breakthrough up to 240 min. | Meets |
Note: The FDA's overall determination of substantial equivalence for the device based on all presented information, including this performance data. The "Do Not Use" recommendation for Carmustine and Thiotepa directly addresses the drugs where breakthrough occurred rapidly.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For each chemotherapy drug, the test set involved 3 specimens of the glove, as indicated by "Specimen 1/2/3" in the "BREAKTHROUGH DETECTION (Specimen 1/2/3) (Minutes)" column.
- Data Provenance: The document does not explicitly state the country of origin of the data. However, the testing was conducted per ASTM D6978-05, which is an American Society for Testing and Materials standard. The study seems to be a prospective evaluation, as new gloves were tested against specific chemicals to determine their performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This device is not an AI device or one that requires clinical expert interpretation for its core functionality. The "ground truth" here is the physical property of the glove's resistance to chemical permeation, which is measured objectively through a standardized laboratory test (ASTM D6978-05). Therefore:
- Number of Experts: Not applicable in the context of expert human interpretation; the "ground truth" is established by the results of a standardized chemical permeation test.
- Qualifications of Experts: Not applicable. The test relies on standardized methodology and instrumentation rather than expert opinion.
4. Adjudication Method for the Test Set
Not applicable. This is a scientific, objective laboratory test. The measurement of breakthrough time for each specimen is a direct outcome of the test procedure, not subject to human adjudication in the sense of reconciling differing opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the goal is often to see how AI assistance improves reader performance. This document describes the chemical resistance of a surgical glove, which is a material property test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a conceptual sense, a "standalone" performance evaluation was done. The device (the surgical glove) was tested without any human "in-the-loop" influencing its chemical resistance or the measurement of that resistance. The test itself measures the intrinsic property of the glove material.
7. The Type of Ground Truth Used
The ground truth used is objective physical measurement data obtained through a standardized laboratory test (ASTM D6978-05). Specifically, it measures the "breakthrough detection time" of various chemotherapy drugs through the glove material.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set." The performance data is derived from direct physical testing of the glove material.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device and study.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).