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510(k) Data Aggregation
(87 days)
The Nitrile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
KIMTECH™ Purple Nitrile™ Examination Gloves, Powder Free, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric acid and Fentanyl in Simulated Gastric acid are single use only, non-sterile, disposable gloves. The powder-free gloves are made of a synthetic copolymer of acrylonitrile and butadiene with a purple color additive. The gloves are available in extra small, medium, large, and extra-large sizes.
This document is a 510(k) Premarket Notification for KIMTECH™ Purple Nitrile™ Powder Free Examination Gloves. It focuses on demonstrating that the proposed device is substantially equivalent to legally marketed predicate devices, particularly concerning its resistance to permeation by chemotherapy drugs, fentanyl citrate, simulated gastric acid, and fentanyl in simulated gastric acid.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the permeation resistance of the gloves are defined by the "Minimum Breakthrough Detection Time" for each substance. For other characteristics, the acceptance criteria are generally "Complies with" or "Pass" based on recognized ASTM and ISO standards.
| Attribute/Test | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Chemotherapy Drugs (Permeation Time) | ASTM D6978-05 (Re-approved 2013): Minimum Breakthrough Detection Time (implied requirement is to demonstrate significant barrier, often >240 min for most drugs but with specific exceptions) | Reported Breakthrough Detection Time (minutes) |
| Blenoxane | >240 | >240 |
| Busulfan | >240 | >240 |
| Carmustine (BiCNU) | (Note: Extremely low permeation time reported) | >3.6 (Warning: Do Not Use With) |
| Cisplatin | >240 | >240 |
| Cyclophosphamide/cytoxan | >240 | >240 |
| Cytarabine | >240 | >240 |
| Dacarbazine (DTIC) | >240 | >240 |
| Daunorubicin | >240 | >240 |
| Docetaxel | >240 | >240 |
| Doxorubicin | >240 | >240 |
| Ellence | >240 | >240 |
| Etoposide/Toposar | >240 | >240 |
| Fludarabine | >240 | >240 |
| Fluorouracil | >240 | >240 |
| Gemcitabine | >240 | >240 |
| Idarubicin | >240 | >240 |
| Ifosfamide | >240 | >240 |
| Irinotecan | >240 | >240 |
| Mechlorethamine HCL | >240 | >240 |
| Melphalan | >240 | >240 |
| Methotrexate | >240 | >240 |
| Mitomycin C | >240 | >240 |
| Mitoxantrone | >240 | >240 |
| Paclitaxel | >240 | >240 |
| Paraplatin | >240 | >240 |
| Rituximab | >240 | >240 |
| Thiotepa | (Note: Extremely low permeation time reported) | >15.9 (Warning: Do Not Use With) |
| Trisenox | >240 | >240 |
| Vincristine Sulfate | >240 | >240 |
| Opioid Fentanyl Citrate (Permeation Time) | ||
| Fentanyl Citrate | >240 | >240 |
| Simulated Gastric Acid (Permeation Time) | ||
| Gastric Acid (simulated) | >240 | >240 |
| Fentanyl in Simulated Gastric Acid (Permeation Time) | ||
| Fentanyl in Gastric Acid | >240 | >240 |
| Dimensions: Overall Length | ASTM D6319 Minimum: 230mm | All sizes comply with length dimensions |
| Dimensions: Width (mean) | ASTM D6319 Minimum: 70 + 10mm (implied range based on standard) | All sizes comply with length dimensions |
| Dimensions: Palm & Finger Thickness | ASTM D6319 Min. Palm: 0.05mm, Finger: 0.05mm | All sizes comply with length dimensions |
| Tensile Strength: Before Aging | ASTM D6319 Min: 14MPa | Complies both before and after accelerated aging |
| Tensile Strength: After Aging | ASTM D6319 Min: 14MPa | Complies both before and after accelerated aging |
| Ultimate Elongation: Before Aging | ASTM D6319 Minimum: 500% | Complies both before and after accelerated aging |
| Ultimate Elongation: After Aging | ASTM D6319 Minimum: 400% | Complies both before and after accelerated aging |
| Freedom from Holes | ASTM D6319 G1, AQL 2.5 (7 Accept, 8 Reject) | Pass |
| Powder-Free | ASTM D6319 Maximum <2mg/glove | Less than 2.0mg per glove; Pass |
| Biocompatibility: Systemic Toxicity | ISO 10993-11: No systemic response in model animal | Under conditions of the study, the device extracts did not elicit a systemic response in the model animal. |
| Biocompatibility: Primary Skin Irritation | ISO 10993-10: Not irritant to animal model | Under conditions of this study, the polar and non-polar device extracts were found not to be an irritant to the animal model. |
| Biocompatibility: Sensitization (Guinea pig Maximization) | ISO 10993-10: Not sensitizers to animal model | Under Conditions of this study, the polar and non-polar device extracts were found not to be sensitizers to the animal model. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for permeation for each drug). However, it references standards like ISO 2859 Sampling Procedures and Tables for Inspection by Attributes, indicating that sampling was conducted according to recognized statistical methods for quality control.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, considering it's a 510(k) submission, the data would typically be derived from laboratory tests conducted for the purpose of the submission. The "Test Results Follow" tables imply that the data presented is the result of direct testing.
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 to this type of device submission. The "ground truth" for glove performance (like permeation, tensile strength, or freedom from holes) is established through physical and chemical testing against defined standards (ASTM, ISO), not through expert consensus or interpretation of complex medical images/data. There are no "experts" establishing a clinical ground truth for these performance tests.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or experts when establishing a clinical ground truth, often in image-based diagnostic studies. For physical device testing, the results are typically quantitative measurements or pass/fail determinations against scientific standards, not subject to human adjudication in that manner.
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. MRMC studies are relevant for AI-powered diagnostic tools where human readers are interpreting medical images or data. This document describes a physical medical device (examination gloves) and its performance against chemical permeation and physical characteristics; it does not involve AI or human readers for diagnostic purposes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is not an algorithm or AI. It is a physical product, and its performance is measured independently in a laboratory setting.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the performance claims of these gloves is based on objective measurements and adherence to established industry standards (ASTM D6978-05 for permeation, ASTM D6319 for physical properties, ISO 10993 for biocompatibility). The results are direct measurements of physical and chemical resistance, not subjective interpretations or clinical outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device. Training sets are used for machine learning algorithms. The performance of these gloves is determined through physical testing, not by training a model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reason stated in point 8.
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