(119 days)
The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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. The proposed device was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs
The document describes the FDA 510(k) clearance for "Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs" and provides details about the testing conducted to support its substantial equivalence.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the study described relates to the glove's resistance to permeation by chemotherapy drugs. The acceptance criterion is implicit in the testing standard used, ASTM D6978-05 (Reapproved 2013), which generally aims for a breakthrough detection time that is sufficient for practical use in a clinical setting (often implying a minimum of 30 minutes, or longer for most drugs).
| Test Chemotherapy Drug | Concentration | Acceptance Criteria (Implied by standard and industry practice) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | Breakthrough > 30 minutes (typical for critical drugs) | 35.3 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Cyclophosphamide (Cytoxan) | 20 mg/ml (20,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Mechlorethamine HCl | 1.0 mg/ml (1,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Methotrexate | 25.0 mg/ml (25,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
| Thiotepa | 10.0 mg/ml (10,000 ppm) | Breakthrough > 30 minutes (typical for critical drugs) | 29.2 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | Breakthrough > 240 minutes (ideal for extended exposure) | >240 |
Note: For FDA 510(k) clearances, performance is compared to a predicate device and/or recognized standards. The "acceptance criteria" here are inferred from the standard and the reported results within the context of safe medical device use. For chemotherapy gloves, the general expectation is that the breakthrough time should be sufficient to allow safe handling, typically indicating more than 30 minutes, and ideally much longer (e.g., >240 minutes) for many drugs. The results show that for most listed drugs, the glove exceeded 240 minutes, while for Carmustine and Thiotepa, it met or nearly met a 30-minute threshold.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for testing each chemotherapy drug. The testing was performed in accordance with ASTM D6978-05 (Reapproved 2013). This standard specifies the methodology for assessing permeation, which would include details on the number of specimens to be tested per drug, but this specific detail is not provided in the publicly available 510(k) letter.
Data Provenance: The study was conducted by Blue Sail Medical Co.,Ltd, located in Zibo, CN (China). The data is prospective in nature, as it involves laboratory testing of the manufactured device to assess its performance against a standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device and study. The "ground truth" for chemical permeation testing is established by laboratory measurement using standardized methods (ASTM D6978-05), not by expert consensus or interpretation of clinical data. The "experts" would be the chemists or technicians performing and verifying the lab tests, who would have qualifications in analytical chemistry and material science.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving interpretation of medical images or data by multiple human readers. This study is a laboratory performance test based on physical and chemical properties.
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 relates to diagnostic accuracy or clinical effectiveness involving human readers and interpretations, which is not relevant to the chemical permeation resistance of gloves.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is irrelevant to the device. "Standalone performance" refers to the performance of an AI algorithm without human input. The device is a physical medical glove, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is laboratory measurement data based on the standardized methodology of ASTM D6978-05 (Reapproved 2013). This standard defines how "breakthrough detection time" is measured, which is a quantified performance metric.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of physical medical devices like gloves. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for a physical medical device.
§ 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.