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510(k) Data Aggregation
(70 days)
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black/White) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with Chemotherapy drugs and Fentanyl using ASTM D6978-05.
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black, White) is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, and single use only, and come in different sizes- XS, S, M, L, XL and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs and Fentanyl Citrate.
The provided document pertains to the 510(k) premarket notification for Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black, White).
This submission is for a Class I medical device (gloves), which typically does not involve complex AI algorithms or diagnostic imaging. Therefore, many of the requested criteria related to AI/MRMC studies, expert consensus for ground truth, and training set information are not applicable to this type of device and submission.
The "acceptance criteria" here refer to the performance standards and safety requirements for medical gloves, particularly their resistance to permeation by chemotherapy drugs and fentanyl, and their physical and biological properties.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents acceptance criteria and reported performance in the "Summary of Non-Clinical Performance Data" and the "Chemotherapy Drugs Comparison Claim" tables.
Table 1: General Performance Acceptance Criteria and Reported Results (from page 10)
| Test Performed | Methodology | Acceptance Criteria | Result |
|---|---|---|---|
| Freedom From Holes | ASTM D6319-19, ASTM D5151-19 | Meet requirement inspection level G-1, AQL 2.5 (ISO2859-1) | Pass |
| Dimension-Length | ASTM D6319-19 | Minimum 230mm for all sizes | Pass |
| Dimension-Width | ASTM D6319-19 | XS: 70±10mm, S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: 120±10mm, XXL: 130±10mm | Pass |
| Dimension-Thickness | ASTM D6319-19 | Finger: 0.05mm (Min), Palm: 0.05mm (Min) | Pass |
| Physical properties | ASTM D6319-19, ASTM D412-16 | Tensile Strength (Min 14 MPa), Elongation (Before Aging 500% and after aging 400% Min) | Pass |
| Powder Residue | ASTM D6319-19, ASTM D6124-06 | Not more than 2 mg per glove | Pass |
| Skin Irritation | ISO10993-23:2021 | Not a primary skin irritant | Pass |
| Skin Sensitization | ISO10993-10:2021 | Not a contact sensitizer | Pass |
| Acute Systemic Toxicity | ISO 10993-11:2017 | No acute systemic toxicity | Pass |
Table 2: Permeation by Chemotherapy Drugs and Fentanyl Citrate Acceptance Criteria and Reported Results (from page 9)
| NO. | Chemotherapy Drugs | Minimum Breakthrough Detection Time, minutes (Black Glove) | Minimum Breakthrough Detection Time, minutes (White Glove) | Predicate Device K230779 (Black) | Result of Comparison (to Predicate) |
|---|---|---|---|---|---|
| 1 | Carmustine (3.3mg/ml) | 14.2 | 16.7 | 11.3 | Different (both subject devices perform better than predicate) |
| 2 | Cisplatin (1mg/ml) | >240 | >240 | >240 | Same |
| 3 | Cyclophosphamide (20mg/ml) | >240 | >240 | >240 | Same |
| 4 | Dacarbazine (10.0 mg/ml) | >240 | >240 | >240 | Same |
| 5 | Doxorubicin HCl (2 mg/ml) | >240 | >240 | >240 | Same |
| 6 | Etoposide (20mg/ml) | >240 | >240 | >240 | Same |
| 7 | Fluorouracil (50mg/ml) | >240 | >240 | >240 | Same |
| 8 | Paclitaxel (6mg/ml) | >240 | >240 | >240 | Same |
| 9 | Thiotepa (10mg/ml) | 14.7 | 16.2 | 24.7 | Different (subject devices perform worse for Thiotepa compared to predicate, but the labeling calls out the warning for these drugs) |
| NO. | Fentanyl Citrate | Minimum Breakthrough Detection Time, minutes (Black Glove) | Minimum Breakthrough Detection Time, minutes (White Glove) | Predicate device K230779 | Result of Comparison |
| 1 | Fentanyl Citrate Injection, 100mcg/2ml | >240 | >240 | >240 | Same |
Note: The warning regarding Carmustine and Thiotepa for both black and white gloves is highlighted due to their low permeation times, similar to the predicate device, which also shows a low time for Carmustine and a higher time for Thiotepa. The critical aspect for these drugs is to provide clear warning on the labeling.
2. Sample size used for the test set and the data provenance
The document specifies that the tests were non-clinical, adhering to various ASTM and ISO standards. These standards prescribe the sample sizes and testing methodologies. For example:
- Freedom from Holes (ASTM D6319-19, ASTM D5151-19): References "inspection level G-I, AQL 2.5 (ISO2859-1)," which indicates specific sampling plans and acceptance quality limits for batch inspection, not individual sample sizes like in a typical clinical study.
- Permeation by Chemotherapy Drugs (ASTM D6978-05): This standard outlines the test method, including the number of specimens (typically 3 specimens per drug per material), continuous monitoring of breakthrough, and reporting of average breakthrough times.
- Biocompatibility (ISO 10993 series): These standards specify the number of animals or in-vitro tests required, but precise numbers are not explicitly stated in this summary.
Data Provenance: The data comes from non-clinical laboratory testing conducted by the manufacturer (Basic Medical Technology Inc.) to demonstrate compliance with recognized industry standards (ASTM, ISO). The document does not specify the country of origin of the raw test data but implies it was generated to support a US FDA submission. The tests are prospective in the sense that they were conducted for this specific submission to demonstrate the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is a physical device (medical gloves) and not an AI/diagnostic software. "Ground truth" in this context is established by standardized, objective laboratory test methods (e.g., measuring dimensions, tensile strength, breakthrough time using analytical instruments), not by expert consensus on clinical images or data.
4. Adjudication method for the test set
Not Applicable. As per point 3, ground truth is established by objective laboratory measurements and adherence to standardized testing protocols, not by expert review or adjudication.
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 a Class I physical medical device (gloves), not an AI algorithm or diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on objective measurements performed according to recognized international and national standards (ASTM, ISO). This includes:
- Physical properties (e.g., dimensions, tensile strength, elongation).
- Chemical resistance (breakthrough time for chemotherapy drugs and fentanyl).
- Biological safety (irritation, sensitization, systemic toxicity).
8. The sample size for the training set
Not Applicable. This is a physical device. There is no AI model or "training set" in the context of this submission. The "training" for the device would be the manufacturing process and quality control, which are governed by Quality System (QS) regulations.
9. How the ground truth for the training set was established
Not Applicable. As explained in point 8, there is no training set as per AI/ML terminology. The manufacturing process and material specifications are developed and validated based on established engineering principles and industry standards to ensure the gloves meet their intended performance characteristics.
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