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510(k) Data Aggregation
(168 days)
The nitrile examination glove is intended to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carboplatin, 10 mg/ml >240 min. Carmustine (BCNU), 3.3 mg/ml 27.5 min Cisplatin, 1.0 mg/ml >240 min Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 min Doxorubicin HCI, 2.0 mg/ml >240 min Etoposide, 20.0 mg/ml >240 min Fluorouracil, 50.0 mg/ml >240 min Paclitaxel, 6.0 mg/ml >240 min Thio Tepa, 10.0 mg/ml 88.2 min
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 27.5 Minutes, Thio Tepa 10.0 mg/ml 88.2 Minutes.
Warning: Please do not use with Carmustine and Thio Tepa.
The proposed device (Mode: NG101) is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are five sizes, include XS (6.5"), S (7"), M (8"), L (8.5"), XL (9") for optional. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge. This is a single-use, powder-free, non-sterile device.
The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019)
The document describes the non-clinical testing performed to demonstrate that the Nitrile Patient Examination Gloves (K221747) meet their acceptance criteria and are substantially equivalent to a predicate device (K211220).
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimension | The actual measured dimension of the gloves shall meet the stated tolerance specified in Table 2 of ASTM D6319-19. | Meet the requirement |
| ASTM D6319-19 | Determination of Physical Properties | Before and after accelerated aging, the gloves shall conform to the physical requirements in Table 3 of ASTM 6319-19 (Tensile Strength: Before Aging ≥ 14 MPa, After Aging ≥ 14 MPa. Elongation: Before Aging 500%, After Aging 400%). | Meet the requirement |
| ASTM D5151-19 | Water Leak Test for Detection of Holes | The gloves shall be free from hole when tested in accordance with the method given in ASTM D5151-19, AQL = 2.5. | Meet the requirement |
| ASTM D6124-06(2017) | Residual Powder Content Test | The powder residue content shall be not more than 2mg per glove. | Meet the requirement |
| ISO 10993-5: 2009 | In Vitro Cytotoxicity | The MEM test extract shows no cytotoxic potential to L929 mouse fibroblast cells. | Meet the requirement |
| ISO 10993-10: 2010 | Skin Sensitization | The test article extracts show no evidence of causing delayed dermal contact sensitization in the guinea pig. | Meet the requirement |
| ISO 10993-10: 2010 | Skin Irritation | There is no erythema and no edema observed on the skin of the animals treated with the test extracts. | Meet the requirement |
| ASTM D6978-05 (Chemotherapy Drugs) | Chemotherapy Drugs (Permeation Breakthrough Time) | Carboplatin, 10 mg/ml >240 min.Carmustine (BCNU), 3.3 mg/ml 27.5 minCisplatin, 1.0 mg/ml >240 minCyclophosphamide (Cytoxan), 20.0 mg/ml >240 minDoxorubicin HCl, 2.0 mg/ml >240 minEtoposide, 20.0 mg/ml >240 minFluorouracil, 50.0 mg/ml >240 minPaclitaxel, 6.0 mg/ml >240 minThio Tepa, 10.0 mg/ml 88.2 min | Except for Carmustine and Thio Tepa, acceptance criteria were met. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each specific test within the non-clinical testing. It generally refers to "Final finished product" as the tested sample. The data provenance is not specified, but it can be inferred that the testing was conducted by or on behalf of the manufacturer, Fitone Latex Products Co., Ltd. Guangdong, which is based in China. The nature of the tests (physical, chemical, and biocompatibility) suggests these were laboratory-based tests on manufactured product samples. The document does not indicate if the data is retrospective or prospective, though it is standard practice for such tests to be prospective assessments of newly manufactured products.
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 tests described are non-clinical, objective measurements against established ASTM and ISO standards for material properties and performance. There is no human interpretation or expert ground truth establishment for these types of tests (e.g., measuring glove dimensions, tensile strength, or chemical permeation).
4. Adjudication method for the test set:
This information is not applicable for the same reason as point 3. Adjudication methods are typically used in studies involving human interpretation or subjective assessments.
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. The submission is for a medical glove, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance comparison was conducted.
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 not an algorithm or AI-based system.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests is based on established industry standards and specifications:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06(2017) (Test Method for Residual Powder on Medical Gloves)
- ASTM D573-04(2019) (Test Method for Rubber-Deterioration in an Air Oven)
- ISO 10993-5: 2009 (Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity)
- ISO 10993-10: 2010 (Biological Evaluation Of Medical Devices Part 10: Tests For Irritation And Skin Sensitization)
- ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs)
These standards define the acceptance criteria (e.g., minimum tensile strength, maximum residual powder, breakthrough times for chemotherapy drugs).
8. The sample size for the training set:
This information is not applicable as there is no training set for a medical glove. These are physical products tested against predetermined specifications.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set.
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