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510(k) Data Aggregation
(103 days)
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.
The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 12.3 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 17.4 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from synthetic polyisoprene latex.
The provided documents describe the acceptance criteria and performance of the Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs. This is a medical device, and the information is presented as part of an FDA 510(k) premarket notification.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the acceptance criteria and device performance is detailed in the "TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE" and the "SUMMARY OF NON-CLINICAL TESTING" sections.
| Characteristic / Test Methodology | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Chemotherapy Drugs Permeation | ASTM D6978-05 (Reapproved 2019): Under the conditions of the study, no permeation. | Carmustine (3.3 mg/ml): 12.3 minutesCisplatin (1.0 mg/ml): > 240 minutesCyclophosphamide (20.0 mg/ml): > 240 minutesDacarbazine (10.0 mg/ml): > 240 minutesDoxorubicin Hydrochloride (2.0 mg/ml): > 240 minutesEtoposide (20.0 mg/ml): > 240 minutesFluorouracil (50.0 mg/ml): > 240 minutesMethotrexate (25.0 mg/ml): > 240 minutesMitomycin C (0.5 mg/ml): > 240 minutesPaclitaxel (6.0 mg/ml): > 240 minutesThiotepa (10.0 mg/ml): 17.4 minutesVincristine Sulfate (1.0 mg/ml): > 240 minutesNote: Carmustine and Thiotepa had extremely low permeation times, leading to a "Do not use" warning. |
| Freedom from Holes | ASTM D3577-19 requirements of AQL 1.5 | Meets ASTM D3577-19 requirements of AQL 1.5 |
| Length (ASTM D3577-19) | Varies by size (e.g., 5.5: Min 245mm, 6.0-9.0: Min 265mm) | Meets ASTM D3577-19 requirements for length (e.g., Size 5.5: 285mm, Size 9.0: 291mm) |
| Width (ASTM D3577-19) | Varies by size (e.g., 5.5: 70 ± 6mm, 9.0: 114 ± 6mm) | Meets ASTM D3577-19 requirements for width (e.g., Size 5.5: 74mm, Size 9.0: 116mm) |
| Thickness (ASTM D3577-19) | Palm, Finger, Cuff Minimum 0.10 mm | Meets ASTM D3577-19 requirements for thickness (e.g., Palm: 0.19-0.21mm, Finger: 0.23-0.24mm, Cuff: 0.15-0.16mm) |
| Tensile Strength (ASTM D3577-19) | Before Aging: ≥ 17 MPaAfter Aging: ≥ 12 MPa | Before Aging: Average 17.9 MPaAfter Aging: Average 15.2 MPa |
| Ultimate Elongation (ASTM D3577-19) | Before Aging: ≥ 650 %After Aging: ≥ 490 % | Before Aging: Average 952 %After Aging: Average 940 % |
| Stress at 500% Elongation (ASTM D3577-19) | Max 7.0 MPa (Before Aging) | Average 2.2 MPa (Before Aging) |
| Powder Residual (ASTM D6124-06 (2017)) | ≤ 2 mg per glove | Average 0.34 mg/glove |
| In Vitro Cytotoxicity (ISO 10993-5) | Not cytotoxic | Found to be cytotoxic, but further evaluation (ISO 10993-11) showed no systemic toxicity. |
| Primary Skin Irritation (ISO 10993-10) | Not an irritant | Not an irritant |
| Dermal Sensitization (ISO 10993-10) | Not a sensitizer | Not a sensitizer |
| Acute Systemic Toxicity (ISO 10993-11) | Does not pose a toxicity concern | No signs of toxicity |
| Pyrogenicity Test (USP <151>) | Non-pyrogenic | Non-pyrogenic |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test in the "test set" (i.e., the data used to prove the device meets acceptance criteria). However, it lists recognized industry standards (ASTM, ISO, USP) for each test. These standards typically define minimum sample sizes for testing to ensure statistical validity.
The data provenance can be inferred based on the applicant information:
- Country of Origin of the Data: The applicant is Hartalega NGC Sdn. Bhd., located in Sepang, Selangor, Malaysia. Therefore, the testing was likely conducted in Malaysia or by laboratories commissioned by the Malaysian company.
- Retrospective or Prospective: These are non-clinical (laboratory) tests performed on the device to demonstrate its properties. This would be considered prospective in the sense that the tests were specifically conducted to evaluate this new device for regulatory submission, not retrospectively analyzed from existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the evaluation relies on objective, standardized laboratory tests (e.g., chemical permeation, physical property measurements, biocompatibility assays) rather than expert interpretation of a "test set" in the context of medical imaging or diagnostic algorithms. The "ground truth" is established by the defined parameters and methodologies of the ASTM, ISO, and USP standards.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation relies on objective, standardized laboratory tests. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers and subjective interpretations, such as radiology image reviews.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "CLINICAL PERFORMANCE DATA: Not applicable. There was no clinical data required to support the subject device as the indication for use is equivalent to the predicate device." MRMC studies are used to evaluate the diagnostic performance of devices, often medical imaging AI, with human-in-the-loop scenarios. This document describes the performance of a physical medical device (surgical glove) through non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical surgical glove, not an algorithm or AI system. The tests evaluate the physical and chemical properties of the glove itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on established standard test methodologies and defined acceptance criteria set by organizations like ASTM, ISO, and USP. These are objective measurements:
- Physical measurements (length, width, thickness)
- Mechanical properties (tensile strength, elongation)
- Chemical resistance (breakthrough time for chemotherapy drugs)
- Biological safety (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity)
It does not involve expert consensus, pathology, or outcomes data in the typical sense of AI/diagnostic device evaluation.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set. The term "training set" refers to data used to train an algorithm.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as Section 8.
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(255 days)
The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU) is nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs -Violet Blue (VBLU)
This document is a 510(k) clearance letter from the FDA for medical examination gloves and does not contain information about an AI-powered medical device or studies related to its performance. Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth.
The document discusses:
- The trade name: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU)
- Regulation Number: 21 CFR 880.6250
- Regulation Name: Patient Examination Glove
- Product Code: LZA
- Indications for Use: Nonsterile disposable device for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner, and tested for use against chemotherapy drugs.
- A table listing specific chemotherapy drugs and their breakthrough times when used with the gloves.
There is no mention of "acceptance criteria" in the context of an algorithm or AI performance, nor is there any study described that would prove an AI device meets acceptance criteria.
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(107 days)
The Nitrile Powder Free Examination Gloves is a non - sterile disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Not Found
This document is an FDA 510(k) clearance letter for various colors of Nitrile Powder Free Examination Gloves. It does not contain any information about acceptance criteria or a study proving that a device meets such criteria, as it is not a submission for an AI/ML or diagnostic device.
Therefore, I cannot provide the requested information. The document focuses on the regulatory clearance of examination gloves, which are assessed based on physical properties and safety rather than performance metrics of an algorithm.
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(97 days)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Orange, White) is non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between and examiner. It is also tested to be used against Chemotherapy Drugs.
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Orange, White)
This document is a 510(k) premarket notification for Nitrile Powder Free Examination Gloves, tested for use with chemotherapy drugs, in blue, orange, and white colors. The primary purpose of this document is to establish substantial equivalence to legally marketed predicate devices and list the indications for use, specifically detailing their resistance to various chemotherapy drugs. This is not a study report demonstrating the performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device cannot be extracted from this document.
The document provides information on the performance of the gloves against chemotherapy drugs, which involves breakthrough times. This is the closest analog to "acceptance criteria" and "device performance" in this context but is related to the physical properties of the gloves, not an AI/ML system.
I will attempt to structure the information based on the glove performance, but please be aware that it does not align with the requested information for an AI/ML study.
Acceptance Criteria and Performance (for the gloves' resistance to chemotherapy drugs):
The acceptance criterion, though not explicitly stated as "acceptance criteria," is the breakthrough time of the glove when exposed to chemotherapy drugs. The device "meets" this by demonstrating the reported breakthrough times, which are then used to inform users about the glove's suitability for different chemotherapy drugs. A longer breakthrough time indicates better protection. The FDA's acceptance of these values implies they are deemed sufficient for the stated indication.
1. Table of Acceptance Criteria and Reported Device Performance:
| Chemotherapy Drugs | Concentration (mg/ml) | Acceptance Criteria (Implicit: Higher is better, FDA approved these values) | Device Performance (Blue Glove) Breakthrough Time (minutes) | Device Performance (Orange Glove) Breakthrough Time (minutes) | Device Performance (White Glove) Breakthrough Time (minutes) |
|---|---|---|---|---|---|
| Carmustine | 3.3 | N/A (See note below table) | 0.1 | 20.3 | 20.4 |
| Cisplatin | 1.0 | N/A (See note below table) | >240 | >240 | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 | N/A (See note below table) | >240 | >240 | >240 |
| Dacarbazine | 10.0 | N/A (See note below table) | >240 | >240 | >240 |
| Doxorubixin Hydrochloride | 2.0 | N/A (See note below table) | >240 | >240 | >240 |
| Etoposide | 20.0 | N/A (See note below table) | >240 | >240 | >240 |
| Fluoroucil | 50.0 | N/A (See note below table) | >240 | >240 | >240 |
| Methotrexate | 25.0 | N/A (See note below table) | >240 | >240 | >240 |
| Mitomycin | 0.5 | N/A (See note below table) | >240 | >240 | >240 |
| Paclitaxel | 6.0 | N/A (See note below table) | >240 | >240 | >240 |
| Thiotepa | 10.0 | N/A (See note below table) | 20.4 | 50.6 | 71.0 |
| Vincristine Sulfate | 1.0 | N/A (See note below table) | >240 | >240 | >240 |
Note on Acceptance Criteria: For these types of medical devices (gloves), the "acceptance criteria" for chemical resistance testing are typically defined by regulatory standards (e.g., ASTM F739 - Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact). While the document does not explicitly state the specific acceptance thresholds, the FDA's clearance of the device indicates that the provided breakthrough times are considered acceptable for the intended use and for informing users about the limitations/capabilities of the gloves. The document "notes the following drugs Carmustine and Thiotepa have extremely low permeation times," which serves as an important user warning based on the test results.
The following numbered points (2-9) are irrelevant to this document as it concerns medical gloves, not an AI/ML device.
2. Sample size used for the test set and the data provenance: Not applicable. This document refers to chemical permeation testing, not a dataset for an AI/ML model. The "test set" in this context would be the gloves themselves subjected to chemical testing. No sample size information for these physical tests is provided in the document. Data provenance is not applicable for an AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for chemical permeation is established through laboratory testing protocols, not expert consensus in the way an AI/ML study would use it.
4. Adjudication method for the test set: Not applicable. This pertains to expert review for AI/ML performance, not physical product testing.
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: Not applicable. This is for AI/ML performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for AI/ML performance evaluation.
7. The type of ground truth used: For the glove performance, the "ground truth" is the empirically measured breakthrough time determined by standardized laboratory methods (e.g., ASTM F739). This is an objective measurement, not expert consensus, pathology, or outcomes data in the context of an AI/ML device.
8. The sample size for the training set: Not applicable. There is no AI/ML training set mentioned or implied in this document.
9. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set mentioned or implied in this document.
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