(37 days)
This device 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 permeation times are as follows: Carmustine (BCNU) 3.3 mg/mL, 11.6 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Dacarbazine (DTIC) 10.0 mg/mL, >240 minutes Doxorubicin 2.0 mg/mL. >240 minutes Etoposide (Toposar) 20.0 mg/mL, >240 minutes Fluorouracil 50.0 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Paclitaxel (Taxol) 6.0 mg/mL, >240 minutes Thiotepa 10.0 mg/mL, 36.2 minutes Vincristine Sulfate 1.0 mg/mL. >240 minutes WARNING: Not for use with Carmustine and Thiotepa.
Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes
Non-sterile, Powder-Pree Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
This document is a 510(k) premarket notification from the FDA, classifying a "Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl" as a Class I device. As such, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance because an AI/ML device is not being submitted.
The requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone performance) would typically be found in regulatory submissions for AI/ML-driven medical devices. However, this document pertains to a medical glove and therefore does not include such details.
§ 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.