# K240021: Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Yue Kang Anhui Medical Products Co., Ltd.
- Decided: Apr 8, 2024 after 96 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.
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)
- K220088: Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Professional Latex Sdn Bhd (2023) Summary page 5.

## Indications for use
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Test Chemotherapy drug are as followings: Test Chemotherapy drug & Concentration Minimum Breakthrough Detection Time (Minutes) Carmustine (BCNU) (3.3mg/ml) 1.3 Cisplatin (1mg/ml) >240 Cyclophosphamide (20mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Doxorubicin HCl (2 mg/ml) >240 Etoposide (20mg/ml) >240 Fluorouracil (50mg/ml) >240 Paclitaxel (6mg/ml) >240 Thiotepa (10mg/ml) 1.1 Test Fentanyl Citrate are as follows: Minimum Breakthrough Detection Time in minutes Fentanyl Citrate Injection 100mcg/2ml >240 Warning: Do not use with Carmustine and Thiotepa. Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.3 minutes and Thiotepa:1.1 minutes.

Source page: https://510kreport.com/device/K240021
Methodology: https://510kreport.com/methodology