# K242533: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Better Care Plastic Technology Co., Ltd.
- Decided: Mar 18, 2025 after 204 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: 4 generations back to K183287 (2019). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232266: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Better Care Plastic Technology Co., Ltd. (2023) 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 and Fentanyl Citrate using ASTM D6978-05. Chemotherapy Drug and Concentration Bleomycin Sulfate 15mg/ml (15000 ppm) Busulfan 6mg/ml (6,000 ppm) Carboplatin 10mg/ml (10,000 ppm) Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) Cisplatin 1mg/ml (1,000 ppm) Cyclophosphamide 20mg/ml (20,000 ppm) Cytarabine HCL, 100 mg/ml (100,000 ppm) Dacarbazine 10 mg/ml (10,000 ppm) Daunorubicin HCL, 5 mg/ml (5,000 ppm) Docetaxel, 10 mg/ml (10,000 ppm) Doxorubicin HCL, 2 mg/ml (2,000 ppm) Epirubicin HCL, 2 mg/ml (2,000 ppm) Etoposide, 20 mg/ml (20,000 ppm) Fludarabine, 25 mg/ml (25,000 ppm) Fluorouracil, 50mg/ml (50,000ppm) Gemcitabine, 38mg/ml (38,000ppm) Idarubicin HCL, Img/ml (1,000ppm) Ifosfamide, 50mg/ml (50,000ppm) Irinotecan, 20mg/ml (20,000ppm) Mechlorethamine HCI, Img/ml (1,000ppm) Melphalan, Smg/ml (5,000ppm) Methotrexate, 25mg/ml (25,000ppm) Mitomycin C, 0.5mg/ml (500ppm) Mitoxantrone HCL, 2mg/ml (2,000ppm) Oxaliplatin, Smg/ml (5,000ppm) Paclitaxel, 6mg/ml (6,000ppm) Paraplatin, 10mg/ml (10,000ppm) Rituximab, 10mg/ml (10,000ppm) Thiotepa, 10mg/ml (10,000ppm) Topotecan, 1mg/ml (1,000ppm) Trisenox, 1mg/ml (1,000ppm) Velcade, Img/ml (1,000ppm) Vincristine Sulfate, 1mg/ml (1,000ppm) Fentanyl Citrate & other drugs Fentanyl Citrate Injection, 100mcg/2mg Chloroquine 50mg/ml (50,000ppm) Cyclosporin A 100 mg/ml (100,000 ppm) Minimum Breakthrough Detection Time (BDT) in Minutes >240 >240 >240 22.8, Do not use >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 >240 46.9, Do not use >240 >240 >240 >240 Minimum Breakthrough Detection Time in Minutes >240 >240 >240 Retrovir, 10mg/ml (10,000ppm) >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/K242533
Methodology: https://510kreport.com/methodology