(52 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, Fentanyl Citrate, and select other drugs using ASTM D6978-05(2019)
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs 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, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and non-sterile.
The provided document describes the acceptance criteria and performance of "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs" (K240051).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions | ||
| Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL, XXL (ASTM D6319-19) | Pass |
| Palm Width (size) | XS: 70±10 mm, S: 80±10 mm, M: 95±10 mm, L: 110±10 mm, XL: 120±10 mm, XXL: 130±10 mm (ASTM D6319-19) | Pass |
| Thickness | Finger: 0.05mm (min), Palm: 0.05mm (min) (ASTM D6319-19) | Pass |
| Physical Properties | ||
| Tensile Strength & Elongation (Before Aging) | Tensile Strength: 14MPa, min; Elongation: 500%, min (ASTM D6319-19, ASTM D412-16(2021)) | Pass |
| Tensile Strength & Elongation (After Accelerated Aging) | Tensile Strength: 14MPa, min; Elongation: 400%, min (ASTM D6319-19, ASTM D412-16(2021)) | Pass |
| Barrier Integrity | ||
| Watertight (1000ml) | G-I, AQL 2.5 (21 CFR 800.20, ASTM D5151-19) | Pass |
| Powder Residue | Max 2mg/glove (ASTM D6319-19, ASTM D6124-06(2017)) | Pass |
| Chemotherapy Drugs & Opioid Drug Permeation | Minimum Breakthrough Detection Time (BDT) for various chemotherapy drugs and Fentanyl Citrate. Accepted values differ by drug, but generally, longer BDT indicates better performance. Specific acceptance criteria are not explicitly listed as a single value but are implied by the reported BDTs (e.g., >240 minutes for many drugs, with lower specific values for Carmustine and Thiotepa which are cautioned against). | See specific BDT values in the tables below for each drug. Notably, Carmustine: 29.1 minutes, Thiotepa: 78.3 minutes. All other listed drugs exhibit >240 minutes BDT. Fentanyl Citrate: >240 minutes. |
| Biocompatibility | ||
| Irritation and Skin Sensitization | Non-sensitization and Non-irritation (ISO 10993-10 & -23) | Non-sensitization and Non-irritation |
| Cytotoxicity | Cytotoxicity reactivity (ISO 10993-5:2009) | Showed potential toxicity to L929 cells, but concern addressed by acute systemic toxicity testing. |
| Acute systemic toxicity study | No adverse biological reaction (ISO 10993-11:2017) | No evidence of acute systemic toxicity. |
Chemotherapy, Fentanyl Citrate & other drugs Permeation Comparison (Proposed Device K240051):
| Tested Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine 3.3 mg/ml (3,300 ppm) | 29.1 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cytarabine, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel , 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine Phosphate, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine HCL, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan HCL, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan HCL, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 78.3 |
| Topotecan HCL, 1mg/ml (1,000ppm) | >240 |
| Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
Warning: Do not use with Carmustine and Thiotepa due to "extremely low permeation times" (29.1 minutes and 78.3 minutes, respectively).
2. Sample size used for the test set and the data provenance:
- The document primarily refers to standard ASTM and ISO test methodologies for device performance (e.g., ASTM D6319-19, ASTM D6978-05(2019), ISO 10993 series). These standards typically define the sample sizes required for each specific test to ensure statistical validity.
- Data Provenance: The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The tests were performed by Lingshi Hongruida Health Protection Technology Co., Ltd. located in China. The data is retrospective in the sense that the testing was performed and then submitted with the 510(k) application. Specific details on exact sample sizes (e.g., number of gloves tested for each characteristic) within each standard are not explicitly detailed in this summary for every test. However, the chemotherapy drug permeation testing likely involved multiple samples per drug as per ASTM D6978.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the device is a physical medical device (examination glove) and the testing involved objective, quantitative, and standardized measurements according to established consensus standards (ASTM, ISO). There were no "experts" establishing a "ground truth" in the way they would for, say, image interpretation or clinical diagnosis. The ground truth for performance relied on the specified chemical and physical property measurements.
4. Adjudication method for the test set:
- This is not applicable. As mentioned above, the testing involved objective physical and chemical measurements governed by established standards, not subjective interpretations requiring adjudication.
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:
- This is not applicable. This device is an examination glove, not an AI-powered diagnostic tool or imaging software. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This device is an examination glove and does not involve any algorithm or AI for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device's performance is based on objective measurements against established performance standards and chemical permeation resistance thresholds.
- For physical properties (length, thickness, tensile strength, elongation, watertightness, powder content): The ground truth is the quantitative measurement compared against the specified ASTM standard values.
- For chemical permeation (chemotherapy drugs, Fentanyl Citrate): The ground truth is the experimentally determined Minimum Breakthrough Detection Time (BDT) in minutes, measured according to ASTM D6978-05(2019).
- For biocompatibility (irritation, sensitization, cytotoxicity, acute systemic toxicity): The ground truth is the experimental findings and conclusions derived from tests conducted under ISO 10993 series standards.
8. The sample size for the training set:
- This is not applicable. This device is a physical product, not a machine learning model, so there is no training set in the context of AI/ML.
9. How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of 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.