(83 days)
The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, 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. The tested drugs are: Chemotherapy drug Concentration Minimum Breakthrough Detection Time Bleomycin sulfate (15.0 mg/ml 15,000 ppm) 240 min Carboplatin (10.0 mg/ml 10,000 ppm) 240 min Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 26.7 Cisplatin (1.0 mg/mL 1,000 ppm) 240 min Cyclophosphamide (20.0 mg/mL 20,000 ppm) 240 min Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) 240 min Dacarbazine (10.0 mg/mL 10,000 ppm) 240 min Doxorubicin HCL (2.0 mg/mL 2,000 ppm) 240 min Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) 240 min Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) 240 min Idarubicin (1.0 mg/ml 1,000 ppm) 240 min Ifosfamide (50.0 mg/mL 50,000 ppm) 240 min Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) 240 min Methotrexate (25.0 mg/mL 25,000 ppm) 240 min Mitomycin C (0.5 mg/mL 500 ppm) 240 min Mitoxantrone HCL (2.0 mg/mL 2,000 ppm 240 min Paclitaxel (6.0 mg/mL 6,000 ppm) 240 min Thiotepa (10.0 mg/mL 10,000 ppm) 37.6 Vincristine Sulfate (1.0 mg/mL 1,000 ppm 240 min Non Chemotherapy Drug MESNA (100.0 mg/mL 100,000 ppm) 240 min Trisenox (1.0 mg/ml 1,000 ppm) 240 min Fentanyl Citrate Injection (100 mcg/2mL) 240 min Note: Carmustine and Thiotepa have extremely low permeation times of 26.7 and 37.6 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa.
The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in four sizes, small, medium and large, extra-large, packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978-05 (Reapproved 2019). The gloves are as same as the Nitrile disposable examination gloves (Model D5000) cleared under K212578 also produced by Xingyu Medical Tech Co., Ltd. The materials and the manufacturing process technology are the same. The proposed device is increased test of Chemotherapy Drug and Fentanyl. Testing has been conducted on the proposed device passed as per ASTM D6978-05 (Reapproved 2019).
This document is a 510(k) Premarket Notification from the FDA regarding "Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl". It does not describe an AI medical device. Therefore, I cannot provide an answer based on the prompt's request for AI-specific acceptance criteria and study details.
The document focuses on the physical and chemical properties of medical gloves, their resistance to certain drugs, and their biocompatibility, which are assessed through standard laboratory testing methods, not AI performance studies.
§ 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.