(134 days)
The Eudermic MP Powder-Free Latex 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.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device, specifically examination gloves. It does not contain information about an AI/ML powered device, acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria. The only performance data included is for the gloves' resistance to chemotherapy drugs. Therefore most of the requested fields cannot be filled.
Below is the information that can be extracted or deduced from the provided text, primarily regarding the glove's performance against chemotherapy drugs.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Breakthrough Detection Time (BDT) for 5-Fluorouracil | >240 min. |
| Breakthrough Detection Time (BDT) for Etoposide (Toposar) | >240 min. |
| Breakthrough Detection Time (BDT) for Cyclophosphamide (Cytoxan) | >240 min. |
| Breakthrough Detection Time (BDT) for Carmustine | 6.26 min. |
| Breakthrough Detection Time (BDT) for Thiotepa | 12.13 min. |
| Breakthrough Detection Time (BDT) for Paclitaxel (Taxol) | >240 min. |
| Breakthrough Detection Time (BDT) for Doxorubicin Hydrochloride | >240 min. |
| Breakthrough Detection Time (BDT) for Dacarbazine (DTIC) | >240 min. |
| Breakthrough Detection Time (BDT) for Cisplatin | >240 min. |
| Breakthrough Detection Time (BDT) for Ifosfamide (Ifex) | >240 min. |
| Breakthrough Detection Time (BDT) for Mitoxantrone | >240 min. |
| Breakthrough Detection Time (BDT) for Vincristine Sulfate | >240 min. |
| Protein Content Label Claim |
§ 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.