(98 days)
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Test Chemotherapy Drug and Concentration | Average BDT |
|---|---|
| Fluorouracil, 50.0mg/ml (50,000ppm) | >240 min. |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 min. |
| Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | >240 min. |
| Carmustine (BCNU), 3.3mg/ml (3,300ppm) | 2.3 min. |
| Thiotepa, 10.0mg/ml (10,000ppm) | 30.9 min. |
| Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | >240 min. |
| Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 min. |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 min. |
| Cisplatin, 1.0mg/ml (1,000ppm) | >240 min. |
Please note that Carmustine and Thiotepa have extremely low permeation times of 30.9 minutes and 2.3 minutes, respectively.
Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM standard D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.
Here's a breakdown of the acceptance criteria and the study information for the Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Product Code | LZA | LZA |
| Intended Use | Disposable non-sterile device for medical purposes, worn on hand/finger to prevent contamination. | Meets |
| Chemotherapy Drugs (Breakthrough Detection Time - BDT) | Fluorouracil, Etoposide, Cyclophosphamide, Paclitaxel, Doxorubicin HCl, Dacarbazine, Cisplatin: >240 min | Fluorouracil (50.0mg/ml): >240 min |
| Etoposide (20.0mg/ml): >240 min | ||
| Cyclophosphamide (20mg/ml): >240 min | ||
| Paclitaxel (6.0mg/ml): >240 min | ||
| Doxorubicin HCl (2.0mg/ml): >240 min | ||
| Dacarbazine (10.0mg/ml): >240 min | ||
| Cisplatin (1.0mg/ml): >240 min | ||
| Carmustine & Thiotepa: Permeation times should be reported. | Carmustine (3.3mg/ml): 2.3 min | |
| Thiotepa (10.0mg/ml): 30.9 min | ||
| Labeling | No special labeling claims, no hypoallergenic claims. | Meets |
| Device Materials | Nitrile compound | Nitrile Compound |
| Color | Blue | Blue |
| Tensile strength (before/after aging) | ASTM D6319-10 (Meets) | Meets |
| Ultimate elongation (before/after aging) | ASTM D6319-10 (Meets) | Meets |
| Freedom from pinholes | ASTM D6319-10, ASTM D5151-06 (2011), 21CFR800.20 (Meets) | Meets |
| Dimensions (Overall length, Width, Palm, Finger thickness) | ASTM D6319-10 (Meets) | Meets |
| Residual powder | ASTM D6319-10, ASTM D6124 (Meets) | Meets |
| Primary skin irritation test | ISO 10993-10 (Not an irritant) | Not an irritant |
| Dermal sensitization assay | ISO 10993-10 (Not a sensitizer) | Not a sensitizer |
| Resistance to Permeation | ASTM D6978-05 (Specific breakthrough times for chemotherapy drugs) | Carmustine: 2.3 minutes |
| Thiotepa: 30.9 minutes | ||
| Other specified drugs: >240 minutes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the individual tests (e.g., tensile strength, pinholes, biocompatibility, resistance to permeation). However, it indicates that the device's physical and performance characteristics meet the requirements of ASTM D 6319-10 and ASTM D 6978-05, which are standards that specify testing methodologies and, implicitly, sample sizes (e.g., AQL levels for pinholes).
The data provenance is from non-clinical tests performed to demonstrate substantial equivalence to a predicate device. The country of origin for the device manufacturer is CHINA (Hebei Province). The testing itself (e.g., ASTM standards, ISO standards) is generally applicable internationally. The document does not specify if the data is retrospective or prospective, but given it's part of a 510(k) submission, it would be considered prospective in the sense that the device was specifically tested to demonstrate compliance for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and study. The "ground truth" for glove performance is established by standardized testing protocols (e.g., ASTM, ISO) that yield quantitative measurements (e.g., tensile strength values, breakthrough detection times, pass/fail for pinholes, irritation/sensitization ratings). There isn't a need for expert consensus in the way there would be for image interpretation or disease diagnosis.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the acceptance criteria are based on objective measurements against established standards, not on subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret results, and the study aims to assess the impact of an AI tool on their performance. For a medical glove, performance is evaluated through physical, chemical, and biological testing as outlined above.
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 (a glove), not an algorithm or AI system. Its performance is inherent to the product itself, not an independent algorithmic output.
7. The Type of Ground Truth Used
The ground truth used for this device is based on:
- Standardized Test Results: Compliance with established industry standards such as ASTM D6319-10 (for physical properties like tensile strength, elongation, dimensions, freedom from holes, residual powder) and ISO 10993-10 (for biocompatibility).
- Quantitative Measurement: For chemotherapy drug permeation, the "ground truth" is the measured breakthrough detection time (BDT), determined according to ASTM D6978-05.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The manufacturing process of the glove and its materials are designed to meet the specifications, and the testing ensures these specifications are met for production batches.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as #8.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.