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510(k) Data Aggregation
(82 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)
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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 provided document describes the acceptance criteria and study results for the "Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K240080).
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the gloves are based on various physical characteristics, chemical permeation resistance (as per ASTM D6978-05(2019)), and biocompatibility tests (as per ISO 10993 standards). The reported device performance is compared to these criteria and, in some cases, to a predicate device (K200671).
Physical and Design Characteristics (Meeting ASTM D6319-19):
| Characteristic | Acceptance Criteria (Subject Device K240080) | Reported Device Performance (Subject Device K240080) |
|---|---|---|
| Length (Minimum) | XS: ≥ 220 mm, S: ≥ 220 mm, M: ≥ 230 mm, L: ≥ 230 mm, XL: ≥ 230 mm, XXL: ≥ 230 mm | Meets ASTM D6319-19 requirements |
| Palm Width (mm) | XS: 70±10, S: 80±10, M: 95±10, L: 110±10, XL: 120±10, XXL: 130±10 | Meets ASTM D6319-19 requirements |
| Thickness (mm) (Minimum) | Finger: 0.05, Palm: 0.05 | Meets ASTM D6319-19 requirements |
| Tensile Strength, Before Aging, min | 14 MPa | 14 MPa |
| Ultimate Elongation, Before Aging, min | 500% | 500% |
| Tensile Strength, After Accelerated Aging, min | 14 MPa | 14 MPa |
| Ultimate Elongation, After Accelerated Aging, min | 400% | 400% |
| Freedom from holes | G-I, AQL 2.5 | G-I, AQL 2.5 |
| Powder residual | ≤ 2 mg per glove | ≤ 2 mg per glove |
Chemotherapy Permeation Resistance (ASTM D6978-05(2019)):
| Chemotherapy Drug | Acceptance Criteria (Minimum Permeation Time from Predicate or Acceptable Performance) | Reported Device Performance (Minimum BDT in Minutes for K240080) |
|---|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | Similar to predicate (23.4 minutes) | 21.2 |
| Cisplatin, 1mg/ml (1000 ppm) | N/A (predicate did not test this) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 |
| Dacarbazine, 10 mg/ml (10,000 ppm) | N/A (predicate did not test this) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 |
| Fluorouracil (5 Flu), 50mg/ml (50,000ppm) | >240 | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 |
| Mitomycin C, 0.5mg/ml (500 ppm) | N/A (predicate did not test this) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | Similar to predicate (64.9 minutes) | 24.9 |
| Vincristine sulfate, 1mg/ml (1000 ppm) | >240 | >240 |
Fentanyl Citrate Permeation Resistance (ASTM D6978-05(2019)):
| Fentanyl Citrate | Acceptance Criteria (Minimum Permeation Time) | Reported Device Performance (Minimum BDT in Minutes for K240080) |
|---|---|---|
| Fentanyl Citrate Injection, 100mcg/2mg | >240 | >240 |
Biocompatibility (ISO 10993 Standards):
| Test | Acceptance Criteria | Reported Device Performance (K240080) |
|---|---|---|
| In vitro Cytotoxicity ISO 10993-5 | Absence of cytotoxicity or similar to predicate (cytotoxic at certain dilutions, non-cytotoxic at others) | Showed potential toxicity to L929 cells (similar to predicate which was cytotoxic at higher concentrations). |
| Acute Systemic Toxicity Test ISO 10993-11 | No evidence of acute systemic toxicity | No evidence of acute systemic toxicity. |
| Dermal Sensitization ISO 10993-10 | No evidence of causing skin sensitization | No evidence of causing skin sensitization. |
| Primary Skin Irritation ISO 10993-23 | Negligible response/not an irritant | Response categorized as negligible under the test condition. |
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 used for each test. However, it indicates that tests were conducted according to recognized international standards such as ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6978-05(2019) (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs), and ISO 10993 series for biocompatibility. These standards typically specify the number of samples required for testing.
The data provenance is not explicitly stated as 'country of origin' in that format, but the applicant is "Syntex Healthcare Products Co., Ltd" from "Xinji, Hebei, China," indicating the testing likely occurred under their purview or by contracted labs. The studies appear to be prospective testing conducted specifically for this premarket notification.
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)
This information is not applicable as the document describes performance testing of a physical medical device (gloves) against established engineering and biocompatibility standards. It does not involve interpretation of medical images or patient data by human experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason as point 3. Testing involves objective measurements against predefined standards.
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 as the device is a medical glove, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on established international and national standards for medical gloves:
- ASTM D6319-19: for physical dimensions and integrity (e.g., freedom from holes, tensile strength).
- ASTM D6978-05(2019): for resistance to permeation by chemotherapy drugs and Fentanyl Citrate, where "breakthrough detection time" is the key metric.
- ISO 10993 series (ISO 10993-5, -10, -11, -23): for biocompatibility assessments like cytotoxicity, sensitization, irritation, and systemic toxicity.
8. The sample size for the training set
This information is not applicable as the device is a physical product and does not involve machine learning or AI models with training sets.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical product and does not involve machine learning or AI models.
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