(124 days)
A patient examination glove 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 per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
The provided document describes the FDA clearance for "Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs" (K220155). This is a medical device, specifically examination gloves, and not an AI/ML powered device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training, are not applicable to this submission.
However, the document does contain information about the acceptance criteria and the study that proves the device meets those criteria for its intended use with chemotherapy drugs.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Chemotherapy Drug Permeation) | Reported Device Performance (Breakthrough Time) |
|---|---|
| >240 minutes for Bleomycin Sulfate, Bortezomib, Busulfan, Carboplatin, Chloroquine, Cisplatin, Cyclophosphamide, Cytarabine, Dacarbazine, Daunorubicin HCl, Docetaxel, Etoposide, Fluorouracil, Gemcitabine, Idarubicin HCl, Ifosfamide, Irinotecan, Mechlorethamine HCl, Melphalan, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel, Triclosan, Trisenox, Vincristine Sulfate. | >240 minutes for the above-listed drugs. |
| Lower permeation times for specifically identified drugs. | 45.4 minutes for Carmustine (BCNU) |
| 15.6 minutes for ThioTepa |
Note: The document explicitly states "WARNING: Not recommended for use with Carmustine and ThioTepa" due to their low permeation times. This indicates that while the testing was performed, the acceptance criteria for these specific drugs effectively resulted in a caveat for their use, highlighting that the "accepted" performance for other drugs is >240 minutes.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set (number of gloves or repetitions of testing). It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). This type of detail is typically found in the full study report, which is not included in this FDA clearance letter.
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 (gloves) and its performance against chemical permeation, not an AI/ML diagnostic or prognostic tool requiring expert ground truth for interpretation. The "ground truth" is the chemical permeation itself, measured objectively.
4. Adjudication method for the test set
Not applicable. As this is not an AI/ML device, there's no "adjudication" in the sense of reconciling expert opinions on diagnoses or interpretations. The permeation testing follows a standardized protocol (ASTM D6978-05).
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this device's performance regarding chemotherapy drug permeation is established through objective laboratory testing following a recognized standard. Specifically, it used ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This standard defines the methodology to measure the breakthrough time of various chemotherapy drugs through the glove material.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in the context of an algorithm.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no training set.
§ 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.