(105 days)
Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves Tested for use with Chemotherapy Drugs are disposable devices intended for medical propose that are worn on the examiner's hands to prevent contamination between patent and examiner.
The proposed device was tested for use with Chemotherapy Drugs as per ASTM D678-05 Standard Practice for Assessment Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drugs Permeation.
Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves Tested for use with Chemotherapy Drugs are disposable devices intended for medical propose that are worn on the examiner's hands to prevent contamination between patent and examiner.
Here's a breakdown of the acceptance criteria and the study information for the Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves, based on the provided FDA 510(k) clearance document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Chemotherapy Drugs | Concentration | Acceptance Criteria (Breakthrough Detection Time) | Reported Device Performance (Breakthrough Detection Time) |
|---|---|---|---|
| Bleomycin Sulfate | 15 mg/ml (15,000 ppm) | >240 min. | >240 min. |
| Busulfan | 6 mg/ml (6,000 ppm) | >240 min. | >240 min. |
| Carboplatin | 10 mg/ml (10,000 ppm) | >240 min. | >240 min. |
| Cisplatin | 1 mg/ml (1,000 ppm) | >240 min. | >240 min. |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | >240 min. | >240 min. |
| Cytarabine HCl | 100 mg/ml (100,000 ppm) | >240 min. | >240 min. |
| Cytovene | 10 mg/ml (10,000 ppm) | >240 min. | >240 min. |
| Dacarbazine | 10 mg/ml (10,000 ppm) | >240 min. | >240 min. |
| Daunorubicin HCl | 5 mg/ml (5,000 ppm) | >240 min. | >240 min. |
| Docetaxel | 10 mg/ml (10,000 ppm) | >240 min. | >240 min. |
| Doxorubicin HCl | 2.0 mg/ml (2,000 ppm) | >240 min. | >240 min. |
| Epirubicin HCl | 2 mg/ml (2,000 ppm) | >240 min. | >240 min. |
| Etoposide | 20.0 mg/ml (20,000 ppm) | >240 min. | >240 min. |
| Fludarabine | 25 mg/ml (25,000 ppm) | >240 min. | >240 min. |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | >240 min. | >240 min. |
| Gemcitabine | 38 mg/ml (38,000 ppm) | >240 min. | >240 min. |
| Idarubicin HCl | 1 mg/ml (1,000 ppm) | >240 min. | >240 min. |
| Ifosfamide | 50 mg/ml (50,000 ppm) | >240 min. | >240 min. |
| Irinotecan | 20 mg/ml (20,000 ppm) | >240 min. | >240 min. |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | >240 min. | >240 min. |
| Melphalan | 5 mg/ml (5,000 ppm) | >240 min. | >240 min. |
| Methotrexate | 25 mg/ml (25,000 ppm) | >240 min. | >240 min. |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 min. | >240 min. |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | >240 min. | >240 min. |
| Oxaliplatin | 2 mg/ml (2,000 ppm) | >240 min. | >240 min. |
| Paclitaxel | 6.0 mg/ml (6,000 ppm) | >240 min. | >240 min. |
| Rituximab | 10 mg/ml (10,000 ppm) | >240 min. | >240 min. |
| Trisenox | 1 mg/ml (1,000 ppm) | >240 min. | >240 min. |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. | >240 min. |
| Vinorelbine | 10 mg/ml (10,000 ppm) | >240 min. | >240 min. |
| Fentanyl Citrate Injection | 100 mcg/2 ml | >240 min. | >240 min. |
| Drugs Not Recommended for Use | |||
| Carmustine (BCNU) | 3.3 mg/ml | Not met (>240 min.) | 34.8 minutes |
| Thiotepa (THT) | 10.0 mg/ml | Not met (>240 min.) | 47.4 minutes |
The device meets the acceptance criteria for all listed chemotherapy drugs by demonstrating a breakthrough detection time of greater than 240 minutes, with the explicit exception of Carmustine and Thiotepa, for which a warning is issued.
2. Sample Size Used for the Test Set and Data Provenance
The document states that the proposed device was "tested for use with Chemotherapy Drugs as per ASTM D678-05 Standard Practice for Assessment Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."
- Sample Size: The document does not explicitly state the number of gloves (samples) tested for each chemotherapy drug. However, ASTM D6978-05 generally specifies a minimum of three individual test specimens per drug for permeation testing.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It implies the data was collected specifically for this submission through testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device and study. The "ground truth" here is objective scientific measurement (chemical breakthrough time) performed by laboratory testing according to a recognized standard (ASTM D6978-05), not expert interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
This section is not applicable. As mentioned above, the "truth" is determined by objective laboratory measurements and standardized methodology, not through human adjudication of differing opinions.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and the impact of AI on their performance. This device is an examination glove, and its performance is measured through physical and chemical interaction, not human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. A "standalone" study (algorithm only) refers to the performance of an AI algorithm independent of human input. This device is a physical product (gloves) whose performance is evaluated through material testing against chemical permeation, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used is objective laboratory measurement of chemical permeation. Specifically, it is the "Breakthrough Detection Time" as measured according to the ASTM D6978-05 standard. This is a direct physical measurement of the glove's resistance to different chemotherapy drugs.
8. The Sample Size for the Training Set
This section is not applicable. This device is a physical product and its performance is evaluated through direct physical/chemical testing, not by training an algorithm on a dataset. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reason as point 8.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.