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510(k) Data Aggregation
(118 days)
A 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powderfree variation of the class I Nitrile Patient Examination Gloves which is coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs and Fentanyl Citrate.
This document describes the testing for Nitrile Examination Gloves, focusing on their resistance to chemotherapy drugs and Fentanyl Citrate. The study assesses the gloves' physical properties, biocompatibility, and chemical permeation alongside the reported device performance.
1. Table of Acceptance Criteria and Reported Device Performance
Chemotherapy and Fentanyl Citrate Permeation (Minimum Breakthrough Detection Time)
| Chemotherapy Drugs | Concentration | Acceptance Criteria (from ASTM D6978-05 implied by claim of use) | Reported Device Performance (Blue Glove) | Reported Device Performance (Black Glove) |
|---|---|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml | No specific public acceptance criterion provided but tested | 22.6 minutes | 21.8 minutes |
| Cisplatin | 1.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Dacarbazine | 10.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Doxorubicin HCl | 2.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Etoposide | 20.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Fluorouracil | 50.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Ifosfamide | 50.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Mitoxantrone | 2 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Paclitaxel | 6.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Thiotepa | 10.0 mg/ml | No specific public acceptance criterion provided but tested | 43.9 minutes | 17.7 minutes |
| Vincristine Sulfate | 1.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Fentanyl Citrate Injection | 100mcg/2ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Warning | Advised against use if permeation time is too low | Carmustine, Thiotepa warning | Carmustine, Thiotepa warning |
Physical Properties, Dimensional, and Biocompatibility Testing
| Test | Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Freedom From Holes | ASTM D6319-19, D5151-19 | Requirement inspection level G-1, AQL 2.5 | Pass |
| Dimension (Length, Thickness, Width) | ASTM D6319-19 | Length: min. 220mm, 230mm. Thickness: min. 0.05mm. Width: 70-120mm (based on size) | Pass (Meets requirements for various sizes) |
| Physical Properties (Before Aging) | ASTM D6319-19 | Tensile Strength: 14 MPa min. Ultimate Elongation: 500% min. | Pass (Meets 14MPa min, 500% min) |
| Physical Properties (After Aging) | ASTM D6319-19 | Tensile Strength: 14 MPa min. Ultimate Elongation: 400% min. | Pass (Meets 14MPa min, 400% min) |
| Residual Powder Content | ASTM D6319-19, D6124-06 | Not more than 2 mg per glove | Pass |
| Primary Skin Irritation Test | ISO 10993-10 | Not a primary skin irritant | Pass (Did not cause an irritant response) |
| Skin Sensitization Test | ISO 10993-10 | Not a contact sensitizer | Pass (Did not produce a skin sensitization effect) |
| In Vitro Cytotoxicity Test | ISO 10993-5:2009 | No adverse biological reaction | Moderate cytotoxicity at 6.0 cm²/mL; No reactivity at 3.0 cm²/mL |
| Acute Systemic Toxicity | ISO 10993-11 | No adverse biological reaction | Pass (No adverse biological reaction) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of gloves) used for the permeation, physical property, or biocompatibility tests.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, the tests were conducted according to international standards (e.g., ASTM, ISO), which implies a standardized, prospective testing approach in a laboratory setting. The applicant is based in Malaysia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving expert readers or ground truth established by medical professionals. The "ground truth" for this device is determined by objective, standardized laboratory measurements (e.g., chemical permeation time, physical properties, biological reactions) as defined by the referenced ASTM and ISO standards.
4. Adjudication Method for the Test Set
Not applicable. There was no human adjudication process involved as the "ground truth" is determined by objective laboratory measurements and adherence to specified test standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The device in question is examination gloves, and its performance is evaluated through physical, chemical, and biological testing, not by human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a medical device (examination gloves), not an AI algorithm. Therefore, the concept of "standalone" performance for an algorithm does not apply. All listed tests are "standalone" in the sense that they assess the intrinsic properties of the glove without human intervention in the measurement process itself, though human technicians conduct and analyze the tests.
7. The Type of Ground Truth Used
The ground truth used for this study is based on:
- Performance Standards: Defined by international standards such as ASTM D6978-05 (for chemotherapy drug permeation), ASTM D6319-19, ASTM D5151-19, ASTM D6124-06 (for physical properties and hole freedom), and ISO 10993-10, ISO 10993-5:2009, ISO 10993-11 (for biocompatibility).
- Objective Laboratory Measurements: Direct measurements of breakthrough time, dimensional properties, tensile strength, elongation, residual powder, and biological response to the glove materials.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned or implied in this submission, as the device is not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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