(255 days)
The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows [Carmustine (BiCNU). Thio-Tepa. Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide and Paclitaxel].
WARNING: DO NOT USE THESE GLOVES WITH THIO-TEPA CAUTION: Testing showed an average breakthrough time of less than 60 minutes with Carmustine.
Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs meet all the requirements of ASTM standard D6978-05, D5712-05e1 and FDA 21 CFR 880.6250.
Here's a breakdown of the acceptance criteria and the study information for the "Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs," based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-00a | Meets |
| Physical Properties | ASTM D6319-00a | Meets |
| Thickness | ASTM D6319-00a | Meets |
| Powder Free | ASTM D6124-01 | Meets (≤ 2 mg/glove) |
| Biocompatibility (Primary Skin Irritation) | - (Implied standard) | Passes (Not a primary skin irritant) |
| Biocompatibility (Dermal Sensitization) | ASTM F-720-81 | Passes (Not a contact sensitizer) |
| Watertight (1000ml) | ASTM D5151-06 | Passes |
| Resistance to permeation by Chemotherapy Drugs | ASTM D6978-05 | Meets requirement |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (dimensions, physical properties, etc.). However, it refers to ASTM standards, which typically outline sampling plans.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It is implied the testing was conducted by the manufacturer (WRP Asia Pacific Sdn Bhd in Malaysia) to meet international standards.
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 the performance characteristics of examination gloves is established through objective physical and chemical testing against recognized industry standards (e.g., ASTM standards), not through expert consensus or interpretation of medical images/data.
4. Adjudication Method for the Test Set
This information is not applicable as there were no subjective assessments requiring adjudication. The tests conducted are objective measurements against predefined criteria.
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 typically performed for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This device is an examination glove, which does not involve human interpretation in the same manner.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was conducted. The device (the glove) itself was tested against the various ASTM standards and performance criteria. There is no "algorithm" or "human-in-the-loop" component in the functionality of an examination glove beyond its intended physical properties.
7. The Type of Ground Truth Used
The ground truth used for this device's testing is based on objective, standardized measurements and criteria defined by established industry standards (ASTM). For example:
- Physical measurements (dimensions, thickness)
- Chemical analysis (powder content)
- Biocompatibility assays (skin irritation, sensitization)
- Barrier integrity tests (watertightness, chemotherapy drug permeation)
8. The Sample Size for the Training Set
This information is not applicable. This device is not an AI/ML-based system that requires a "training set" in the conventional sense. The manufacturing process and quality control would involve ongoing testing, but there isn't a "training set" like there would be for an algorithmic model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 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.