# K250578: Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)

- Pathway: 510(k) (Special)
- Applicant: Careglove Global Sdn. Bhd.
- Decided: Apr 1, 2025 after 33 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)
- K230121: Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black), Careglove Global Sdn. Bhd. (2023) Summary page 5.

## Indications for use
A patient examination glove 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. Table below shows the Summary Test Result for Resistance of Nitrile Powder Free Examination Glove (Blue & Black) to Permeation by Chemotherapy Drugs and Fentanyl Citrate. Chemotherapy Drugs and Fentanyl Citrate — Concentration — Minimum Breakthrough Detection Time (minutes): Blue; Black *Carmustine (BCNU) — 3.3 mg/ml — 22.6; 21.8 Cisplatin — 1.0 mg/ml — >240 min; >240 min Cyclophosphamide (Cytoxan) — 20.0 mg/ml — >240 min; >240 min Dacarbazine — 10.0 mg/ml — >240 min; >240 min Doxorubicin HCL — 2.0 mg/ml — >240 min; >240 min Etoposide — 20.0 mg/ml — >240 min; >240 min Fluorouracil — 50.0 mg/ml — >240 min; >240 min Ifosfamide — 50.0 mg/ml — >240 min; >240 min Mitoxantrone — 2 mg/ml — >240 min; >240 min Paclitaxel — 6.0 mg/ml — >240 min; >240 min *Thio Tepa — 10.0 mg/ml — 43.9; 17.7 Vincristine Sulfate — 1.0 mg/ml — >240 min; >240 min Methotrexate — 25.0 mg/ml — >240 min; >240 min Mitomycin C. — 0.5 mg/ml — >240 min; >240 min Fentanyl Citrate — 100mcg/2ml — >240 min; >240 min *Please note that following drugs have extremely low permeation times: 1. Carmustine (BCNU) 2. Thio Tepa Warning: Do not use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K250578
Methodology: https://510kreport.com/methodology