(119 days)
The device is a disposable examination glove made of synthetic rubber intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner or when handling cytotoxic drugs listed below:
- Carmustine (BiCNU);
- Cyclophosphamide;
- Doxorubicin Hydrochloride;
- 5-Fluorouracil;
- Cisplatin;
- Etoposide;
- Paclitaxel:
- Thio-Tepa
- Dacarbazine
The device is a disposable examination glove made of synthetic rubber intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner or when handling cytotoxic drugs listed below:
- Carmustine (BiCNU);
- Cyclophosphamide;
- Doxorubicin Hydrochloride;
- 5-Fluorouracil;
- Cisplatin;
- Etoposide;
- Paclitaxel:
- Thio-Tepa
- Dacarbazine
The provided document is a 510(k) clearance letter from the FDA for "Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemo Therapy Drugs". This document does not contain any information about acceptance criteria or a study proving device performance related to an AI/ML context.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices, allowing the manufacturer to market it. The "acceptance criteria" mentioned in the request refer to performance metrics typically used for AI/ML devices (e.g., sensitivity, specificity, AUC), while this document is for a physical medical glove.
Therefore, I cannot extract the requested information from this document.
§ 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.