(74 days)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Is it also tested to be used against Chemotherapy Drugs.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
This document is a 510(k) premarket notification for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)". It is not a study report for an AI/ML powered device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text.
The document primarily focuses on establishing substantial equivalence for a physical medical glove. The key "performance" aspect here is the glove's resistance to chemotherapy drugs, which is presented as part of its "Indications for Use."
Here's the information that can be extracted or inferred from the provided text, related to the device and its claimed performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated as Breakthrough Time Thresholds) | Reported Device Performance (Breakthrough Time) |
|---|---|
| Sufficient protection against chemotherapy drugs (implied) | Carmustine (3.3 mg/ml): 22.2 minutes |
| Cisplatin (1.0 mg/ml): > 240 minutes | |
| Cyclophosphamide (20 mg/ml): > 240 minutes | |
| Dacarbazine (10.0 mg/ml): > 240 minutes | |
| Doxorubicin Hydrochloride (2.0 mg/ml): > 240 minutes | |
| Etoposide (20 mg/ml): > 240 minutes | |
| Fluorouracil (50 mg/ml): > 240 minutes | |
| Methotrexate (25 mg/ml): > 240 minutes | |
| Mitomycin C (0.5 mg/ml): > 240 minutes | |
| Paclitaxel (6.0 mg/ml): > 240 minutes | |
| Thiotepa (10.0 mg/ml): 37.3 minutes | |
| Vincristine Sulfate (1.0 mg/ml): > 240 minutes |
Note: The document explicitly highlights, "Please note that Carmustine and Thiotepa have extremely low permeation times of 22.2 minutes and 37.3 minutes," which serves as a crucial piece of information for users regarding the limitations of the glove with these specific drugs.
The remaining requested points are not applicable or cannot be determined from the provided text, as they pertain to the evaluation of an AI/ML device, not a physical glove:
- 2. Sample sized used for the test set and the data provenance: Not applicable to a physical glove's chemotherapy resistance testing. The document doesn't detail the number of gloves tested.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for chemotherapy drug breakthrough is based on laboratory testing, not medical expert consensus.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI-powered device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the chemotherapy resistance, the ground truth is established through laboratory testing to determine breakthrough times.
- 8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
- 9. How the ground truth for the training set was established: 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.