(443 days)
Powder Free Nitrile Examination Gloves, Non-Sterile, and tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam gloves which is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM-D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Examination Gloves, Non-Sterile, and Tested for Juse with Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the-counter single use. It is an ambidextrous, light blue colour device with wide range of sizes, i.e (XS, S, M, L and XL). It is designated for single use only.
The document describes the acceptance criteria and performance data for the "Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate". This is a medical device, and the evaluation focuses on its physical properties, chemical permeation resistance, and biocompatibility.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test | Standard | Acceptance Criteria | Reported Device Performance | Outcome |
|---|---|---|---|---|
| Physical Properties | ||||
| Length (Physical Dimension) | ASTM D6319-10 | Min 240mm | Min 240mm | Passed |
| Thickness Palm & Finger (Physical Dimension) | ASTM D6319-10 | Min 0.05mm | Min 0.05mm | Passed |
| Width by sizes (XS, S, M, L, XL) (Physical Dimension) | ASTM D6319-10 | XS - 70mm, S - 80mm, M - 95mm, L - 110mm, XL - 120mm (Tolerance: ± 10mm) | XS - 70mm, S - 80mm, M - 95mm, L - 110mm, XL - 120mm (Tolerance: ± 10mm) | Passed |
| Tensile Strength Before Aged (Physical Properties) | ASTM D6319-10 | Min: 14MPa | Min: 14MPa | Passed |
| Tensile Strength After Aged (Physical Properties) | ASTM D6319-10 | Min: 14MPa | Min: 14MPa | Passed |
| Ultimate Elongation Before Aged (Physical Properties) | ASTM D6319-10 | Min 500% | Min 500% | Passed |
| Ultimate Elongation After Aged (Physical Properties) | ASTM D6319-10 | Min 400% | Min 400% | Passed |
| Powder Content (Powder Residual) | ASTM D6124-06(2017) | Powder Amount: 240 | > 240 | Met Target/Passed |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Dacarbazine (10.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Doxorubicin HCI (2.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Etoposide (20.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Fluorouracil (50.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Ifosfamide (50.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Methotrexate (25.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Mitomycin C (0.5 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Mitoxantrone (2.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Paclitaxel (6.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Vincristine Sulfate (1.0 mg/ml) | > 240 | > 240 | Met Target/Passed | |
| Carmustine (BCNU) (3.3 mg/ml) | > 240 (implied target for general safe use, but specific low time is reported) | 24.3 | Not Met (explicitly warned against use) | |
| ThioTepa (10.0 mg/ml) | > 240 (implied target for general safe use, but specific low time is reported) | 48.6 | Not Met (explicitly warned against use) | |
| Fentanyl Citrate Injection (100.0 mcg/2ml) | ASTM D6978 | > 240 | > 240 | Met Target/Passed |
Note on Cytotoxicity: The document states the cytotoxicity test "Failed" for the subject device based on the acceptance criteria of "No Cytotoxicity Reaction," as it exhibited severe cytotoxicity at higher concentrations (100% and 66% extract concentrations). However, it notes no cytotoxicity at lower concentrations (44%, 30%, 20%, 15%). The comparison table states "undiluted, 1:2 and 1:4 dilution is cytotoxicity and the dilution 1:8 and 1:16 and 1:32 us non-cytotoxic," and then concludes "Same" when comparing to the predicate device's cytotoxicity results. This implies that this level of cytotoxicity at higher concentrations is considered acceptable within the context of substantial equivalence, despite failing a generic "No Cytotoxicity Reaction" criteria. The device is still cleared, usually meaning the risk is mitigated or assessed as acceptable for the intended use.
Note on Carmustine and ThioTepa: For Carmustine and ThioTepa, the breakthrough times are explicitly stated as "extremely low" and the warning "Do not use with Carmustine and ThioTepa" is included in the Indications for Use and the summary. This indicates these permeation times are not meeting the general acceptance criteria of > 240 minutes for safe use with chemotherapy drugs, and the device is therefore not indicated for use with these specific drugs.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of gloves, batches) used for each individual test. It lists the standards followed (e.g., ASTM D6319-10, ASTM D6124-06(2017), ASTM D5151-19, ISO 10993, ASTM D6978-2005). These standards typically define sampling plans, but the specific number of units tested is not reported in this summary.
The data provenance is from non-clinical tests conducted by the manufacturer, Professional Latex Sdn Bhd, located in Malaysia. The tests are reported as demonstrating that the proposed device met all design specifications according to the listed standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For medical device performance testing as described (physical, chemical, biocompatibility), "ground truth" is established by the specified test methods in the standards (e.g., ASTM for physical properties and chemical permeation, ISO for biocompatibility). These tests usually involve laboratory analysis and measurements rather than expert consensus on interpretation of, for instance, medical images. The results are objective measurements against predefined criteria.
4. Adjudication method for the test set
This is not applicable as the tests are primarily objective measurements against established standard criteria, not subjective interpretations requiring adjudication by experts.
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 document pertains to the safety and performance testing of a physical medical device (examination gloves), not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document is not about an algorithm or AI.
7. The type of ground truth used
The "ground truth" for the acceptance criteria is based on:
- Standardized Test Methods and Specifications: For physical properties (e.g., length, thickness, tensile strength, elongation, powder content, freedom from holes), the ground truth is defined by the requirements of international and national standards such as ASTM D6319-10, ASTM D6124-06(2017), and ASTM D5151-19.
- Permeation Resistance Measurement: For chemotherapy drugs and fentanyl citrate, the ground truth is the measured breakthrough detection time according to ASTM D6978-2005.
- Biocompatibility Standards: For irritation, sensitization, cytotoxicity, and acute systemic toxicity, the ground truth is determined by the Pass/Fail criteria defined within ISO 10993 standards (ISO 10993-10, ISO 10993-5, ISO 10993-11).
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The testing described is for physical product validation.
9. How the ground truth for the training set was established
Not applicable. (See 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.