# K222449: Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Better Care Plastic Technology Co., Ltd.
- Decided: Aug 27, 2022 after 12 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: 2 generations back to K183287 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192954: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Comfort Rubber Gloves Industries Sdn. Bhd. (2020) Summary page 4.

## 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 Carmustine 3.3 mg/ml (3,300 ppm) 11.2 Cisplatin 1mg/ml (1,000 ppm) >240 Cyclophosphamide 20mg/ml (20,000 ppm) >240 Dacarbazine 10 mg/ml (10,000 ppm) >240 Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240 Etoposide, 20 mg/ml (20,000 ppm) >240 Fluorouracil, 50mg/ml (50,000ppm) >240 Methotrexate, 25mg/ml (25,000ppm) >240 Paclitaxel, 6mg/ml (6,000ppm) >240 Thiotepa, 10mg/ml (10,000ppm) 294 Fentanyl Citrate Injection (100 mcg/2ml) >240 Fentanyl Citrate Injection (100 mcg/2ml) >240 Please note that the following drugs have extremely low permeation times: Carmustine: 11.2 minutes, Thio Tepa: 21.6 minutes *Warning: Do not use with Carmustine and Thio Tepa.

Source page: https://510kreport.com/device/K222449
Methodology: https://510kreport.com/methodology