(200 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Non-Sterile, PF Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs - Blue
The provided document is a 510(k) clearance letter from the FDA for "Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs - Blue." This document does not describe an AI/ML powered device, but rather a standard medical device.
Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for an AI device is not applicable to this document.
The document does include a table indicating the performance of the gloves with various chemotherapy drugs, specifically the "Average Breakthrough Detection Time." This table could be interpreted as describing device performance against acceptance criteria for chemotherapy drug permeation, but it is not related to AI/ML performance.
Acceptance Criteria and Reported Device Performance (as related to chemotherapy drug permeation for the gloves):
| Tested Chemotherapy Drug And Concentration | Acceptance Criteria (Implicit: > 240 minutes where stated otherwise) | Reported Device Performance (Average Breakthrough Detection Time) |
|---|---|---|
| Carboplatin, 10 mg/ml | (Not explicitly stated, but common industry standard for high resistance) | >240 minutes |
| Carmustine 3.3 mg/ml | (Not explicitly stated) | 11.3 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | (Not explicitly stated) | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | (Not explicitly stated) | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | (Not explicitly stated) | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | (Not explicitly stated) | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | (Not explicitly stated) | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | (Not explicitly stated) | > 240 minutes |
| Ifosfamide , 50.0 mg/ml | (Not explicitly stated) | > 240 minutes |
| Methotrexate, 25 mg/ml | (Not explicitly stated) | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | (Not explicitly stated) | > 240 minutes |
| Mitoxantrone, 2 mg/ml | (Not explicitly stated) | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | (Not explicitly stated) | > 240 minutes |
| ThioTEPA (10.0 mg/ml) | (Not explicitly stated) | 7.4 minutes |
| Vincristine Sulfate, 1.0 mg/ml | (Not explicitly stated) | > 240 minutes |
The document states that "Carmustine (3.3 mg/ml): 11.3 minutes" and "ThioTEPA (10.0 mg/ml): 7.4 minutes" have "extremely low permeation time," which implies that for these drugs, the gloves do not offer extended protection. This information would be crucial for users to understand the limitations of the device.
All other requested information about an AI/ML study is not present in this document as it is not a submission for an AI/ML 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.