(78 days)
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentaryl Citrate, and Select Other Drugs 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.
These gloves were tested for use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and 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, Extra Extra Large. 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 provided non-sterile.
The provided documentation describes the non-clinical performance testing of a medical device, specifically Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs (K233598). The study aims to demonstrate that the device meets acceptance criteria and is substantially equivalent to a predicate device (K223713).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by various ASTM and ISO standards, and the reported performance indicates that the device passed these criteria. The key performance metrics are related to physical dimensions, physical properties (tensile strength, elongation), freedom from holes, residual powder, permeation by chemotherapy drugs and fentanyl citrate, and biocompatibility.
| Methodology / Test Performed | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|
| ASTM D6319-19: Physical Dimensions (Length) | Minimum 220mm for size XS and S; 230mm for size M, L, XL | 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 | Before aging: 14MPa, min (Tensile Strength); 500%, min (Ultimate Elongation) | |
| After aging: 14MPa, min (Tensile Strength); 400%, min (Ultimate Elongation) | Pass | |
| ASTM D6319-19, ASTM D5151-19: Water Leak Test | G-I, AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017): Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019): Permeation by Chemotherapy Drugs | Most Drugs: >240 minutes (e.g., Bendamustine HCl, Bleomycin sulfate, Carboplatin, etc.) | |
| Carmustine (3.3 mg/ml): 1.7 minutes | ||
| ThioTepa (10 mg/ml): 0 minutes | Meets stated values (see table) | |
| ASTM D6978-05 (2019): Permeation by Fentanyl Citrate | Fentanyl Citrate Injection (100 mcg/2ml): >240 minutes | >240 min. |
| ASTM D6978-05 (2019): Permeation by Select Other Drugs | Chloroquine (50mg/ml), Cyclosporin A (100mg/ml), Retrovir (10 mg/ml): >240 minutes | >240 min. |
| ISO 10993-10:2021: Skin Sensitization | No Skin Sensitization | The sample extract elicits no sensitization reactions under the test conditions. |
| ISO 10993-23:2021: Irritation | No Skin Irritation | Under the conditions of this study, the irritation response category of the test article is classified as Negligible for polar extract and Negligible for non-polar extract. |
| ISO 10993-11:2017: Acute Systemic Toxicity Study | Subject showed no adverse biological reaction | No death or acute systemic toxicity was observed in the mice which received injection of the extract. |
Important Note on Chemotherapy Drugs: The document explicitly states: "Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.7 minutes and Thiotepa: 0 minute. Warning: Do not use with Carmustine and Thiotepa." This means that while the glove was tested against these drugs, its performance for them is below the typical acceptable threshold for chemotherapy gloves (which is usually >240 minutes for other drugs), and this is a critical aspect of its labeling and intended use.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the exact sample sizes (number of gloves or individual tests) used for each performance test. It only refers to the standards (e.g., ASTM D6319-19, ASTM D6978-05), which would specify the required sample sizes for testing. For instance, ASTM D6319-19 defines AQL (Acceptable Quality Level) for certain tests (e.g., G-I, AQL 2.5 for water leak test), which implies specific sampling plans.
- Data Provenance: The tests were non-clinical performance studies. The data provenance is linked to the manufacturer, Anhui Intco Medical Products Co., Ltd., China. The tests are described as having been "conducted to verify that the proposed device met all design specifications," implying a prospective testing approach within a laboratory setting, rather than retrospective analysis of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for glove performance (e.g., tensile strength, breakthrough time, freedom from holes) is established through standardized laboratory testing methods (ASTM, ISO), not through expert consensus or clinical judgment of images or patient data. The results are objective, measurable physical properties and chemical resistance.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly in image interpretation, where human readers might disagree, and a consensus or majority opinion is needed to establish ground truth. For the physical and chemical performance tests of gloves, the results are quantitative and objective, determined by laboratory equipment and standardized procedures.
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 AI-powered diagnostic devices where human readers interpret medical images or data. The device in question is a medical glove, a physical barrier, not a diagnostic tool requiring human interpretation with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not applicable. The device is a physical product (a glove), not an algorithm or software. Therefore, there is no "algorithm only" performance to evaluate. The tests performed are on the physical properties and chemical resistance of the glove itself.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on:
- Standardized Measurement: Directly measurable physical properties (e.g., length, width, thickness, tensile strength, elongation, residual powder).
- Controlled Chemical Permeation Tests: Breakthrough detection times for specific hazardous chemicals (chemotherapy drugs, fentanyl citrate).
- Biological Testing: In-vivo (animal) and in-vitro tests for biocompatibility (skin irritation, sensitization, acute systemic toxicity) as defined by ISO standards.
Essentially, the "ground truth" is defined by the established and validated protocols of the cited ASTM and ISO standards for testing medical gloves.
8. The Sample Size for the Training Set
This information is not applicable. This submission is for a physical medical device (a glove) that undergoes manufacturing processes and performance testing, not an artificial intelligence (AI) or machine learning (ML) algorithm. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
This information 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.