# K230121: Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)

- Pathway: 510(k) (Traditional)
- Applicant: Careglove Global Sdn. Bhd.
- Decided: May 15, 2023 after 118 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.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213408: BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free, Meditech Gloves Sdn Bhd (2022) Summary page 7.

## Most influential descendants
- K250578: Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (2025), 0 descendants of its own
- K232252: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) (2023), 0 descendants of its own

## 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 per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drugs Concentration Minimum Breakthrough Detection Time (Minutes) *Carmustine (BCNU) 3.3 mg/ml 22.6 Cisplatin 1.0 mg/ml >240 min Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min Dacarbazine 10.0 mg/ml >240 min Doxorubicin HCI 2.0 mg/ml >240 min Etoposide 20.0 mg/ml >240 min Fluorouracil 50.0 mg/ml >240 min Ifosfamide 50.0 mg/ml >240 min Mitoxantrone 2 mg/ml >240 min· Paclitaxel 6.0 mg/ml >240 min *Thiotepa 10.0 mg/ml 43.9 Vincristine Sulfate 1.0 mg/ml >240 min Fentanyl Citrate Injection 100mcg/2ml >240 min *Please note that following drugs have extremely low permeation times: Carmustine (BCNU) 3 .3mg/ml 22.6 minutes Thiotepa 10.0mg/ml 43.9 minutes Warning: Do not use these gloves with Carmustine or Thiotepa. 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 per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drugs Concentration Minimum Breakthrough Detection Time (Minutes) *Carmustine (BCNU) 3.3 mg/ml 21.8 Cisplatin 1.0 mg/ml >240 min Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min Dacarbazine 10.0 mg/ml >240 min Doxorubicin HCl 2.0 mg/ml >240 min Etoposide 20.0 mg/ml >240 min Fluorouracil 50.0 mg/ml >240 min Ifosfamide 50.0 mg/ml >240 min Mitoxantrone 2 mg/ml >240 min Paclitaxel 6.0 mg/ml >240 min *Thiotepa 10.0 mg/ml 17.7 Vincristine Sulfate 1.0 mg/ml >240 min Fentanyl Citrate Injection 100mcg/2ml >240 min *Please note that following drugs have extremely low permeation times: Carmustine (BCNU) 3.3mg/ml 21.8 minutes Thiotepa 10.0mg/ml 17.7 minutes Warning: Do not use these gloves with Carmustine or Thiotepa.

Source page: https://510kreport.com/device/K230121
Methodology: https://510kreport.com/methodology