# K232266: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Better Care Plastic Technology Co., Ltd.
- Decided: Nov 3, 2023 after 95 days
- Product code: LZA (Polymer Patient Examination Glove)
- 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.
3 later devices descend from it; 3 cite it directly.
0 of 7 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.

## Most influential descendants
- K260703: Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl (2026), 0 descendants of its own
- K242533: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2025), 0 descendants of its own
- K240629: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (2024), 0 descendants of its own

## 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 and Fentanyl Citrate using ASTM D6978-05(2019) Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes Bleomycin Sulfate 15mg/ml (15000 ppm) >240 Busulfan 6mg/ml (6,000 ppm) >240 Carboplatin 10mg/ml (10,000 ppm) >240 Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 22.8 Chloroquine 50mg/ml (50,000ppm) >240 Cisplatin 1mg/ml (1,000 ppm) >240 Cyclophosphamide 20mg/ml (20,000 ppm) >240 Cyclosporin 100 mg/ml (100,000 ppm) >240 Cytarabine HCL, 100 mg/ml (100,000 ppm) >240 Dacarbazine 10 mg/ml (10,000 ppm) >240 Daunorubicin HCL, 5 mg/ml (5,000 ppm) >240 Docetaxel, 10 mg/ml (10,000 ppm) >240 Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240 Epirubicin HCL, 2 mg/ml (2,000 ppm) >240 Etoposide, 20 mg/ml (20,000 ppm) >240 Fludarabine, 25 mg/ml (25,000 ppm) >240 Fluorouracil, 50mg/ml (50,000ppm) >240 Gemcitabine, 38mg/ml (38,000ppm) >240 Idarubicin HCL, 1mg/ml (1,000ppm) >240 Ifosfamide, 50mg/ml (50,000ppm) >240 Irinotecan, 20mg/ml (20,000ppm) >240 Mechlorethamine HCI, 1mg/ml (1,000ppm) >240 Melphalan, 5mg/ml (5,000ppm) >240 Methotrexate, 25mg/ml (25,000ppm) >240 Mitomycin C, 0.5mg/ml (500ppm) >240 Mitoxantrone HCL, 2mg/ml (2,000ppm) >240 Oxaliplatin, 5mg/ml (5,000ppm) >240 Paclitaxel, 6mg/ml (6,000ppm) >240 Paraplatin, 10mg/ml (10,000ppm) >240 Retrovir, 10mg/ml (10,000ppm) >240 Rituximab, 10mg/ml (10,000ppm) >240 Thiotepa, 10mg/ml (10,000ppm) 46.9 Topotecan, 1mg/ml (1,000ppm) >240 Trisenox, 1mg/ml (1,000ppm) >240 Velcade, 1mg/ml (1,000ppm) >240 Vincristine Sulfate, 1mg/ml (1,000ppm) >240 Fentanyl Citrate Injection (100 mcg/2ml) >240 Please note that the following drugs have extremely low permeation times: Carmustine: 22.8 minutes, Thiotepa: 46.9 minutes, *Warning: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K232266
Methodology: https://510kreport.com/methodology