(80 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
The provided text describes the acceptance criteria and performance of Powder Free Nitrile Examination Gloves, specifically focusing on their resistance to chemotherapy drugs and Fentanyl Citrate. It does not describe an AI/ML-based medical device. Therefore, many of the requested details about AI/ML specific studies (MRMC, standalone algorithm, training/test set ground truth establishment, expert qualifications, etc.) are not applicable to this document.
However, I can extract information related to the acceptance criteria and "studies" (non-clinical performance tests) conducted for this glove device.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Test Performed) | Reported Device Performance (Results) |
|---|---|
| Physical Dimensions (ASTM D6319-19) | |
| Length: Minimum 230mm for all sizes | Pass |
| Palm Width: XS: 70±10mm, S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: 120±10mm, XXL: 130±10mm | Pass |
| Thickness: Finger: 0.05mm (min), Palm: 0.05mm (min) | Pass |
| Physical Properties (ASTM D6319-19, ASTM D412-16(2021)) | |
| Tensile Strength (Min 14 MPa) and Elongation (Before Aging 500% and After Aging 400%) Min | Pass |
| Water leak test (ASTM D6319-19, ASTM D5151-19) | AQL 2.5 (ISO 2859-1) - Pass |
| Powder Residue (ASTM D6319-19, ASTM D6124-06 (2017)) | Max 2mg/glove - Pass |
| Permeation by Chemotherapy Drugs (ASTM D6978-05 (2019)) | |
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.3 minutes |
| Cisplatin 1mg/ml (1,000 ppm) | >240 minutes |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 minutes |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 minutes |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 minutes |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 minutes |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 minutes |
| Methotrexate, 25mg/ml (25,000ppm) | >240 minutes |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 minutes |
| Thiotepa, 10mg/ml (10,000ppm) | 24.7 minutes |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 minutes |
| Biocompatibility (ISO 10993-10 & 23:2021, ISO 10993-5:2009, ISO 10993-11:2017) | |
| Irritation and Skin Sensitization (Skin sensitization and Skin irritation) | Non-sensitization and Non-irritation |
| Cytotoxicity (Cytotoxicity reactivity) | Showed potential toxicity to L929 cells. (Note: Predicate device also showed cytotoxicity at higher concentrations but not at lower, suggesting this is an expected characteristic of the material at certain concentrations and likely within acceptable limits for a device of this type, given the "Similar" comparison to the predicate). |
| Acute systemic toxicity study (Subject showed no adverse biological reaction) | No evidence of systemic toxicity. |
2. Sample size used for the test set and the data provenance:
- The document refers to "Non-clinical tests" and lists various ASTM and ISO standards used. It does not specify the exact sample sizes used for each test beyond the requirements of these standards (e.g., AQL 2.5 for water leak test implies a specific sampling plan).
- Data Provenance: The document does not explicitly state the country of origin of the data for these non-clinical tests. It refers to Shanxi Hongjin Plastic Technology Co., Ltd. in China, which suggests the tests were likely performed in relation to their manufacturing and quality control processes. The tests are retrospective (i.e., performed on manufactured gloves to confirm compliance).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this is a physical device (gloves) and the "ground truth" is established by adherence to physical and chemical testing standards (e.g., measuring dimensions, tensile strength, breakthrough detection time for chemicals per ASTM/ISO standards). These are objective measurements, not subjective expert interpretations of images or other data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for physical/chemical testing. The tests have defined methodologies and acceptance criteria.
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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" for these tests is the objective measurement against established physical/chemical standards (e.g., actual dimensions, measured tensile strength, breakthrough time as defined by ASTM D6978-05). It's based on scientific and engineering measurements, not expert consensus, pathology, or outcomes data in a medical context.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device. There is no concept of a "training set" for physical product testing.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.
§ 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.