(81 days)
The Mediguard Powder-Free Nitrile Examination Glove (tested for use with chemotherapy drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Chemotherapy Drug | Average BDT |
|---|---|
| 5-Fluorouracil | >240 min. |
| Etoposide (Toposar) | >240 min. |
| Cyclophosphamide (Cytoxan) | >240 min. |
| Carmustine | 1.10 min. |
| Thiotepa | 8.13 min. |
| Paclitaxel (Taxol) | >240 min. |
| Doxorubicin Hydrochloride | >240 min. |
| Dacarbazine (DTIC) | >240 min. |
| Cisplatin | >240 min. |
| Ifosfamide (Ifex) | >240 min. |
| Mitoxantrone | >240 min. |
| Vincristine Sulfate | >240 min. |
| WARNING: Do not use with Carmystine and Thio-Te |
The Mediguard Powder-Free Nitrile Examination Glove (tested for use with chemotherapy drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This document describes the FDA's clearance of the Mediguard Powder-Free Nitrile Examination Glove for medical purposes, including use with certain chemotherapy drugs. This is not a study of an AI/ML device, but rather a regulatory approval for a medical device (examination glove). Therefore, the specific information requested about acceptance criteria and studies related to AI/ML performance, such as sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details, do not apply to this document.
However, I can extract the acceptance criteria for the chemotherapy drug breakthrough times and the reported device performance from the provided table.
1. A table of acceptance criteria and the reported device performance
For examination gloves tested for use with chemotherapy drugs, the key performance metric is the "Breakthrough Detection Time (BDT)", which signifies the time it takes for a chemotherapy drug to penetrate the glove material. Although explicit "acceptance criteria" for BDT aren't stated as numerical thresholds in this document, the implicit acceptance standard is that a longer BDT is better, ideally exceeding the typical exposure time during handling. For some drugs, the glove showed exceptional resistance (>240 minutes), while for others (Carmustine, Thiotepa), the resistance was very low, leading to a warning.
| Chemotherapy Drug | Reported Device Performance (Average BDT) | Implicit Acceptance/Performance Standard (Longer is better) |
|---|---|---|
| 5-Fluorouracil | >240 min. | High resistance (exceeded 240-minute test duration) |
| Etoposide (Toposar) | >240 min. | High resistance (exceeded 240-minute test duration) |
| Cyclophosphamide (Cytoxan) | >240 min. | High resistance (exceeded 240-minute test duration) |
| Carmustine | 1.10 min. | Very low resistance (explicit warning issued) |
| Thiotepa | 8.13 min. | Low resistance (explicit warning issued) |
| Paclitaxel (Taxol) | >240 min. | High resistance (exceeded 240-minute test duration) |
| Doxorubicin Hydrochloride | >240 min. | High resistance (exceeded 240-minute test duration) |
| Dacarbazine (DTIC) | >240 min. | High resistance (exceeded 240-minute test duration) |
| Cisplatin | >240 min. | High resistance (exceeded 240-minute test duration) |
| Ifosfamide (Ifex) | >240 min. | High resistance (exceeded 240-minute test duration) |
| Mitoxantrone | >240 min. | High resistance (exceeded 240-minute test duration) |
| Vincristine Sulfate | >240 min. | High resistance (exceeded 240-minute test duration) |
Note: The explicit "WARNING: Do not use with Carmustine and Thio-Tepa" indicates that for these two drugs, the reported breakthrough times (1.10 min and 8.13 min respectively) were considered unacceptable by the manufacturer/FDA for safe use, despite being measured values.
The remaining requested information (2-9) is not applicable or cannot be extracted from this document as it pertains to AI/ML device studies, which this FDA clearance is not.
§ 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.