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510(k) Data Aggregation
(125 days)
A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specially glove has also been tested with Chemotherapy drugs and the Opioid Fentanyl citrate.
The K212613 gloves are produced as nitrile synthetic gloves. They are manufactured without natural rubber latex. The nitrile gloves are blue in color, disposable, single-use only, non-sterile, medical examination gloves. K212613 meets all the requirements of ASTM D6978-10(2019) Standard Specifications for Examination Gloves for Medical Applications. They have been tested for use with chemotherapy drugs and the opioid Fentanyl citrate, both of which were evaluated using ASTM D6378-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The provided document describes the acceptance criteria and performance of Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue). The evaluation is based on non-clinical performance tests, not clinical studies involving human or animal subjects. Therefore, sections related to human reader studies, ground truth establishment by experts, and training set information are not applicable.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6978-2005 (2019) | Permeation by Chemotherapy Drugs | Minimum breakthrough detection time > 240 minutes for most drugs | All Chemotherapy Drugs & the Opioid passed >240 min except Carmustine (13.0 min) & ThioTepa (37.9 min) |
| ASTM D412-2016 | Physical properties (Tensile strength) | Minimum 14 Mpa | Pass |
| ASTM D412-2016 | Physical properties (Elongation) | Minimum 400% | Pass |
| ASTM D5151-19 | Water-leak test | AQL 1.5 (ISO 2859-1) | Pass |
| ASTM D6124-06 (2017) | Residual powder test | < 2mg/glove | Pass |
| ISO 10993-10:2010 (2016) | Dermal Irritation | Under conditions of this study, the subject device is non-irritating | Pass |
| ISO 10993-10:2010 (2016) | Skin Sensitization | Under conditions of this study, the subject device is non-sensitizing | Pass |
| ISO 10993-11: Tests for Systemic Toxicity | Systemic Toxicity (Biocompatibility) | Under the conditions of the Systemic Toxicity test, the predicate glove showed no adverse biological reaction. | Passes (Subject device used ISO 10993-11 as an accepted alternative to the predicate's ISO 10993-5) |
| ISO 10993-5 (Cytotoxicity) | Cytotoxicity (Biocompatibility) | Not explicitly stated for subject device, but predicate passed at certain concentrations | Not directly tested for subject device; ISO 10993-11 Acute Systemic Toxicity was used as an accepted alternative |
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) used for each non-clinical test. The tests are standard industry tests (e.g., ASTM, ISO standards) typically performed by manufacturers and independent labs. The data provenance is from the manufacturer's testing (Koon Seng Sdn. Bhd. located in Malaysia) or accredited laboratories performing these standard tests. These are non-clinical, controlled laboratory tests, not retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the evaluation is based on objective, non-clinical laboratory tests according to specified standards, not expert interpretation of outputs like in AI/imaging studies.
4. Adjudication method for the test set
This is not applicable as the evaluation is based on objective, non-clinical laboratory tests.
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
No such study was done. This device is an examination glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical product (gloves), not an algorithm. The tests performed are standalone evaluations of the glove's physical and chemical resistance properties.
7. The type of ground truth used
The "ground truth" for the performance criteria is defined by established international and national standards for medical gloves (e.g., ASTM D6978, ASTM D412, ASTM D5151, ASTM D6124, ISO 10993). These standards specify the test methodologies and acceptable limits for physical properties, chemical permeation, and biocompatibility.
8. The sample size for the training set
This is not applicable as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
This is not applicable as this is not a machine learning or AI device. The "ground truth" for the performance of the gloves is established by adherence to the objective criteria and methods outlined in the mentioned ASTM and ISO standards for medical devices and materials.
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