(91 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).
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) 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 glove has biodegradation property within landfills tested per ASTM D5511.
The provided text describes the acceptance criteria and study results for "Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)".
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Length | Minimum 220mm for size XS-S; Minimum 230mm for size M-XXL | Pass |
| ASTM D6319-19 | Physical Dimensions Palm Width | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions Thickness | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min 14 Mpa); Elongation (Before Aging 500% and after aging 400% Min) | Pass |
| ASTM D6319-19, ASTM D5151-19 | Freedom from holes | AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | ≤ 2 mg per glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs and Fentanyl Citrate | Minimum Breakthrough Detection Time (BDT) for various drugs (as detailed in the tables below) | Pass (for claimed drugs) |
| ISO 10993-10 & 23:2021 | Irritation and Skin Sensitization | Non-sensitization and Non-irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity (no specific acceptance criteria listed, but result indicates toxicity) | showed potential toxicity to L929 cells. |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity. |
| ISO 11737-1:2018 | Open box bioburden study | No significant increase in bioburden | Pass |
Chemotherapy Drug and Fentanyl Citrate Permeation Performance:
Black Glove:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 23.0 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 45.9 |
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
Green Glove:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 15.4 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 34.4 |
| Fentanyl Citrate Injection, 100mcg/2mg | >240 |
Warnings: Do not use with Carmustine and Thiotepa due to extremely low permeation times.
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 specific sample sizes for each test in the acceptance criteria. However, compliance with ASTM and ISO standards for products like medical gloves typically involves defined sample sizes for testing (e.g., AQL levels for freedom from holes). The data provenance is not specified, but the testing was conducted to international standards (ASTM, ISO). Given this is a 510(k) submission for a physical device (gloves), the testing is prospective, performed on the manufactured product.
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):
Not applicable. This device is a physical product (medical gloves) and its performance is evaluated against engineering and material standards (ASTM, ISO), along with chemical permeation resistance. There is no human interpretative element requiring expert consensus or ground truth in the way medical imaging AI devices do. The "ground truth" here is the result of standardized physical and chemical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As this is not an AI/diagnostic device, there is no adjudication process involving human experts to establish ground truth from data.
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 an AI medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI medical device. The tests performed are standalone in the sense that the device itself is subjected to a test, and its performance is measured directly against predefined criteria without human intervention in the result determination beyond operating the testing equipment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by standardized laboratory testing protocols and predefined limits specified in international standards (ASTM D6319-19, ASTM D6978-05 (2019), ISO 10993 series, etc.). For example, the minimum tensile strength, elongation percentages, AQL for holes, and breakthrough detection times for chemicals are directly measured and compared against the specified numerical criteria from these standards.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI/machine learning model. Therefore, there is no "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 device, this question is not relevant.
§ 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.