# K243959: Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Lingshi Hongruida Health Protection Technology Co., Ltd.
- Decided: Feb 24, 2025 after 63 days
- Product code: LZC (Medical Glove, Specialty)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K183287 (2019). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221269: Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Better Care Plastic Technology Co., Ltd. (2022) Summary page 6.

## Indications for use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs, Fentanyl Citrate and Other Select Drugs using ASTM D6978-05(2019) Chemotherapy Drug & Concentration Minimum Breakthrough Detection Time in Minutes Violet Black Green Bleomycin Sulfate 15mg/ml (15000 ppm) >240 >240 >240 Busulfan 6mg/ml (6,000 ppm) >240 >240 >240 Carboplatin 10mg/ml (10,000 ppm) >240 >240 >240 Carmustine 3.3 mg/ml (3,300 ppm) 15.3 12.6 11.7 Cisplatin 1mg/ml (1,000 ppm) >240 >240 >240 Cyclophosphamide 20mg/ml (20,000 ppm) >240 >240 >240 Cytarabine, 100 mg/ml (100,000 ppm) >240 >240 >240 Dacarbazine 10 mg/ml (10,000 ppm) >240 >240 >240 Daunorubicin HCL, 5 mg/ml (5,000 ppm) >240 >240 >240 Docetaxel , 10 mg/ml (10,000 ppm) >240 >240 >240 Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240 >240 >240 Epirubicin HCL, 2 mg/ml (2,000 ppm) >240 >240 >240 Etoposide, 20 mg/ml (20,000 ppm) >240 >240 >240 Fludarabine, 25 mg/ml (25,000 ppm) >240 >240 >240 Fluorouracil, 50mg/ml (50,000ppm) >240 >240 >240 Gemcitabine, 38mg/ml (38,000ppm) >240 >240 >240 Idarubicin HCL, 1mg/ml (1,000ppm) >240 >240 >240 Ifosfamide, 50mg/ml (50,000ppm) >240 >240 >240 Irinotecan HCL, 20mg/ml (20,000ppm) >240 >240 >240 Mechlorethamine HCI, 1mg/ml (1,000ppm) >240 >240 >240 Melphalan HCL, 5mg/ml (5,000ppm) >240 >240 >240 Methotrexate, 25mg/ml (25,000ppm) >240 >240 >240 Mitomycin C, 0.5mg/ml (500ppm) >240 >240 >240 Mitoxantrone HCL, 2mg/ml (2,000ppm) >240 >240 >240 Oxaliplatin, 5mg/ml (5,000ppm) >240 >240 >240 Paclitaxel, 6mg/ml (6,000ppm) >240 >240 >240 Paraplatin, 10mg/ml (10,000ppm) >240 >240 >240 Rituximab, 10mg/ml (10,000ppm) >240 >240 >240 Thiotepa, 10mg/ml (10,000ppm) 36.4 15.4 33.0 Topotecan HCL, 1mg/ml (1,000ppm) >240 >240 >240 Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) >240 >240 >240 Velcade (Bortezomib) 1mg/ml (1,000ppm) >240 >240 >240 Vincristine Sulfate, 1mg/ml (1,000ppm) >240 >240 >240 Fentanyl Citrate & Other Drugs Minimum Breakthrough Detection Time in Minutes Violet Black Green Fentanyl Citrate Injection, 100mcg/2mg >240 >240 >240 Chloroquine 50mg/ml (50,000ppm) >240 >240 >240 Cyclosporin A 100 mg/ml (100,000 ppm) >240 >240 >240 Retrovir, 10mg/ml (10,000ppm) >240 >240 >240 *Please note that the following drugs have extremely low permeation times: Carmustine: 15.3 minutes, Thiotepa: 36.4 minutes (Violet); Carmustine: 12.6 minutes, Thiotepa: 15.4 minutes (Black); Carmustine: 11.7 minutes, Thiotepa: 33.0 minutes (Green); Warning: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K243959
Methodology: https://510kreport.com/methodology