(213 days)
The Medline Powder-Free Nitrile Examination Glove with Aloe (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 | 19.31 min. |
| Thiotepa | 26.88 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 Carmustine and Thio-Tepa.
Medline Powder-Free Nitrile Examination Glove with Aloe (Green) - Tested for use with Chemotherapy Drugs
This request is about a medical glove, not an AI/ML device, so many of the requested fields are not applicable.
Here's a breakdown of the available information regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Chemotherapy Drug | Acceptance Criteria (Breakthrough Detection Time) | Reported Device Performance (Average BDT) |
|---|---|---|
| 5-Fluorouracil | Not explicitly stated, implied to be acceptable | >240 min. |
| Etoposide (Toposar) | Not explicitly stated, implied to be acceptable | >240 min. |
| Cyclophosphamide (Cytoxan) | Not explicitly stated, implied to be acceptable | >240 min. |
| Carmustine | Not explicitly stated, implied to be unacceptable | 19.31 min. |
| Thiotepa | Not explicitly stated, implied to be unacceptable | 26.88 min. |
| Paclitaxel (Taxol) | Not explicitly stated, implied to be acceptable | >240 min. |
| Doxorubicin Hydrochloride | Not explicitly stated, implied to be acceptable | >240 min. |
| Dacarbazine (DTIC) | Not explicitly stated, implied to be acceptable | >240 min. |
| Cisplatin | Not explicitly stated, implied to be acceptable | >240 min. |
| Ifosfamide (Ifex) | Not explicitly stated, implied to be acceptable | >240 min. |
| Mitoxantrone | Not explicitly stated, implied to be acceptable | >240 min. |
| Vincristine Sulfate | Not explicitly stated, implied to be acceptable | >240 min. |
Note: The document explicitly states a "WARNING: Do not use with Carmustine and Thio-Tepa," which implies that the breakthrough detection times for these two drugs (19.31 min and 26.88 min, respectively) were not considered acceptable for safe use. For the other drugs, the ">240 min" result demonstrates acceptable performance, likely exceeding an unstated minimum threshold for chemotherapy drug resistance.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The data is presented as "Average BDT," suggesting multiple tests were conducted for each drug, but the number of gloves or drug exposures is not given.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to a physical medical device like a glove. The "ground truth" for glove performance with chemotherapy drugs is established through standardized laboratory testing protocols, not expert clinical assessment.
4. Adjudication method for the test set:
- Not applicable. As this is not an AI/ML device relying on human interpretation, there's no adjudication method in the traditional sense. The breakthrough detection times are objective measurements from laboratory tests.
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 a physical medical device. The "standalone" performance refers to the glove's inherent resistance to chemotherapy drugs, as measured in a lab.
7. The type of ground truth used:
- Laboratory Testing Results: The ground truth is the experimentally determined "Breakthrough Detection Time (BDT)" for each chemotherapy drug when tested against the glove material. This is an objective, quantitative measurement derived from standardized testing methods (though the specific standard is not stated in this document).
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.