(152 days)
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentany1 Citrate 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. It is for over-the- counter use.
In addition, these gloves were tested for use with Chemotherapy Citrate in accordance with ASTM D6978-05, Standards Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The subject device in this 510(k) Notification is a Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. The subject device is a patient examination glove made from nitrile rubber compound, Cornflower Blue color, powder-free, and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, the Standard Specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs and fentanyl citrate.
This document is a 510(k) Premarket Notification from ECO Medi Glove Sdn. Bhd. for their Cornflower Blue Powder Free Nitrile Examination Glove, which has been tested for use with chemotherapy drugs and Fentanyl Citrate. The document summarizes the device's characteristics, its intended use, and the performance criteria it meets based on non-clinical testing.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Chemotherapy & Fentanyl Permeation (ASTM D6978-05) | ||
| Carmustine (3.3mg/ml) | Minimum Breakthrough detection time: Not specified as a strict acceptance criteria, but predicate's performance was 7.28 minutes for comparison. The subject device should demonstrate comparable or better performance for substantial equivalence. | 15.4 minutes (Note: A warning is issued not for use with Carmustine due to low permeation time) |
| Cyclophosphamide (20mg/ml) | Minimum Breakthrough detection time: Not specified, but predicate's performance was >240 minutes. | >240 minutes |
| Cytarabine (100mg/ml) | Minimum Breakthrough detection time: Not specified, but predicate's performance was >240 minutes. | >240 minutes |
| Doxorubicin HCl (2.0mg/ml) | Minimum Breakthrough detection time: Not specified, but predicate's performance was >240 minutes. | >240 minutes |
| Etoposide (20mg/ml) | Minimum Breakthrough detection time: Not specified, but predicate's performance was >240 minutes. | >240 minutes |
| Fluorouracil (50mg/ml) | Minimum Breakthrough detection time: Not specified, but predicate's performance was >240 minutes. | >240 minutes |
| Methotrexate (25mg/ml) | Minimum Breakthrough detection time: Not specified, but predicate's performance was >240 minutes. | >240 minutes |
| Paclitaxel (6mg/ml) | Minimum Breakthrough detection time: Not specified, but predicate's performance was >240 minutes. | >240 minutes |
| Thiotepa (10mg/ml) | Minimum Breakthrough detection time: Not specified as a strict acceptance criteria, but predicate's performance was 2.67 minutes for comparison. The subject device should demonstrate comparable or better performance for substantial equivalence. | 56.2 minutes (Note: A warning is issued not for use with ThioTepa due to low permeation time) |
| Fentanyl Citrate Injection (100mg/2ml) | Minimum Breakthrough detection time: Not specified, but reference device's performance was No breakthrough time at 240 minutes. | >240 minutes |
| Physical (ASTM D6319-19) | ||
| Overall Length (mm) | XS, S: Min 220mm; M, L, XL, XXL: Min 230mm | Meets ASTM D6319-19 |
| Width (±10mm) | XXS = 65mm; XS = 70mm; S = 80mm; M = 95mm; L = 110mm; XL = 120mm; XXL = 130mm | ISO 2859-1 / S2/AQL 4.0 |
| Thickness at Palm (mm) | Min: 0.05 mm | ISO 2859-1 / S2/AQL 4.0 |
| Thickness at Finger Tip (mm) | Min: 0.05 mm | Meets ASTM D6319-19 |
| Tensile Strength (MPa) - Before Aging | 14min | Meets ASTM D6319-19 |
| Ultimate Elongation (%) - Before Aging | 500min | Meets ASTM D6319-19 |
| Tensile Strength (MPa) - After Aging (70°C for 168 hrs @ 100°C for 22 hrs) | 14min | Meets ASTM D6319-19 |
| Ultimate Elongation (%) - After Aging | 400min | Meets ASTM D6319-19 |
| Freedom from Pinholes (ASTM D5151-19) | AQL 2.5, Inspection Level G-1 | Meets ASTM D5151-19 |
| Powder-free Residue (ASTM D6124-06(2022)) | ≤2.0 mg/pc | Meets ASTM D6124-06(2022) |
| Biocompatibility | ||
| Irritation (ISO 10993-23:2021) | Not an irritant | Pass (test article was a non-irritant) |
| Sensitization (ISO 10993-10:2021) | Not a sensitizer | Pass (test article was a non-sensitizer) |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Not induce acute systemic toxicity | Pass (did not induce any acute systemic toxicity) |
Study Proving Device Meets Acceptance Criteria:
The document indicates that the device meets the acceptance criteria through non-clinical testing. These tests were conducted according to established international and national standards.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for permeation, number of samples for physical properties, number of animals for biocompatibility). It references the standards used, which typically define the required sample sizes for such tests. For example, for "Freedom from Pinholes," it mentions "AQL 2.5, Inspection Level G-1" which implies a sampling plan based on the number of units in a lot. For "Width" and "Thickness" it references "ISO 2859-1 / S2/AQL 4.0," also indicating a sampling scheme.
- Data Provenance: The document does not explicitly state the country of origin of the data. However, given that the manufacturer is ECO Medi Glove Sdn. Bhd. located in Taiping, Perak Darul Ridzuan, Malaysia, it is highly probable that the testing was conducted in Malaysia or contracted to a testing facility recognized in the region. The data is retrospective, as it's a summary of tests already performed for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable in this context. The "ground truth" here is defined by objective physical and chemical measurements according to standardized test methods (ASTM, ISO). There is no "expert consensus" or "clinical ground truth" involved in evaluating the performance of examination gloves against these specific criteria. The standards themselves, developed by expert committees, define the acceptable levels.
4. Adjudication Method for the Test Set:
This information is not applicable. Since the evaluation involves objective measurements against predefined criteria in recognized standards, there is no need for an adjudication method by human readers or experts in the way it would be for a diagnostic medical device reading images or interpreting clinical 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:
This information is not applicable. This device is a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI assistance is entirely irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. As stated above, this device is a medical glove and does not involve any algorithms or AI for standalone performance evaluation.
7. The Type of Ground Truth Used:
The "ground truth" in this context is established by:
- Standardized Test Methods: Adherence to widely accepted national and international standards such as ASTM D6978-05 (for chemotherapy drug permeation), ASTM D6319-19 (for physical properties and dimensions), ASTM D5151-19 (for pinholes), ASTM D6124-06(2022) (for powder-free residue), and ISO 10993 series (for biocompatibility).
- Objective Measurement Data: The results of the tests conducted in accordance with these standards provide the "ground truth" for whether the glove meets the defined performance characteristics. For breakthrough times, it's the measured time; for physical properties, it's the quantitative values compared to minimum/maximum thresholds; for biocompatibility, it's the qualitative assessment (Pass/Fail) based on biological response.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" in the context of physical product testing for a medical glove. The testing performed is to verify the manufactured product meets defined specifications.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reason as in 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.