(98 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Powder Free Nitrile Examination Glove (Blue). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. Low Dermatitis Potential Tested For Use With Chemotherapy Drugs.
The provided text describes a 510(k) premarket notification for a medical device: "Powder Free Nitrile Examination Glove (Blue), This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole, Low Dermatitis Potential, Tested for Use With Chemotherapy Drugs."
This document is a regulatory clearance letter and does not contain the acceptance criteria or a study description in the format of a typical scientific or clinical study. It refers to the device's substantial equivalence to legally marketed predicate devices and mentions that the glove "has been tested for use with specific chemotherapy drugs."
However, based on the information provided, we can infer some details related to acceptance criteria and performance for the chemotherapy drug permeation testing, which is a specific claim for this device.
Here's an attempt to structure the available information per your request, recognizing the limitations of the source document:
1. Table of Acceptance Criteria and Reported Device Performance (Chemotherapy Drug Permeation)
The "Indications for Use" section lists specific chemotherapy drugs and their "Average Breakthrough Detection Time in Minutes." While not explicitly stated as "acceptance criteria," the listed times for each drug represent the performance achieved, and for most, a ">240 minute" breakthrough time is implied as a desirable (and likely passed) threshold for safe use. The specific values obtained for each drug would be the "reported device performance."
| Chemotherapy Drug | Acceptance Criteria (Implied) | Reported Device Performance (Average Breakthrough Detection Time in Minutes) |
|---|---|---|
| Dacarbazine (DTIC) | >240 minutes | >240 |
| Cyclophosphamide (Cytoxan) | Sufficiently High (e.g., >60 minutes for some standards) | 69.59 |
| Doxorubicin Hydrochloride | >240 minutes | >240 |
| 5-Fluorouracil | >240 minutes | >240 |
| Cisplatin | >240 minutes | >240 |
| Etoposide | >240 minutes | >240 |
| Paclitaxel (Taxol) | >240 minutes | >240 |
Note: The document explicitly states "Warning: Do Not Use With Thiotepa or Carmustine," indicating that the device did not meet acceptance criteria for these specific drugs or was not tested for them in a way that would deem it safe.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in this regulatory letter. For permeation testing, this typically involves multiple glove samples tested per drug.
- Data Provenance: Not explicitly stated (e.g., country of origin). The applicant, Smart Glove Corporation Sdn. Bhd., is based in MALAYSIA. It's common for testing to be conducted in a laboratory setting, which could be in various locations. The data is retrospective relative to the submission date of the 510(k).
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 performance test (chemotherapy drug permeation), not a diagnostic or interpretative study requiring human experts for ground truth establishment. The "ground truth" is determined by laboratory testing methods (e.g., spectrophotometry or chromatography to detect drug breakthrough).
4. Adjudication method for the test set
- Not Applicable. As this is a laboratory performance test, there isn't a need for expert adjudication in the same way there would be for a clinical diagnostic study. Measurements are typically objective based on standardized test methods.
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 physical device (glove) and not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device. Standalone algorithm performance refers to AI systems without human intervention, which is not relevant here.
7. The type of ground truth used
- Laboratory Testing / Standardized Test Methods: The "ground truth" for the chemotherapy drug permeation testing would be the objective measurement of drug breakthrough time through the glove material. This is established by specific, standardized laboratory protocols, likely following methods like ASTM D6978 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of this physical device performance testing. Training sets are relevant for machine learning or AI models.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not applicable.
§ 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.