# K192954: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl

- Pathway: 510(k) (Traditional)
- Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
- Decided: Jun 19, 2020 after 242 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: 1 generation back to K183287 (2019). 1 ancestor in all.
26 later devices descend from it; 11 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183287: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Kossan International Sdn Bhd (2019) Summary page 5.

## Most influential descendants
- K221269: Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2022), 8 descendants of its own
- K232266: Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2023), 3 descendants of its own
- K213408: BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free (2022), 3 descendants of its own
- K230779: Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2023), 2 descendants of its own
- K230121: Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (2023), 2 descendants of its own

## Indications for use
The Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a patient medical exam glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Average Breakthrough Detection Time (minutes) Cisplatin 1.0 mg/ml ≥ 240 Cyclophosphamide (Cytoxan) 20 mg/ml ≥ 240 Dacarbazine (DTIC) l 0.0 mg/ml ≥ 240 Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Etoposide (Toposar) 20.0 mg/ml ≥ 240 Fluorouracil 50.0 mg/ml ≥ 240 Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Carmustine (BCNU) -3.3 mg/ml 18.2 Thiotepa (THT) -10.0 mg/ml 57.3 Tested Fentanyl Citrate is as follows: Average Breakthrough Detection Time Fentanyl Citrate Injection 100.0 mcg/2ml (minutes) ≥ 240 Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 18.2 minutes and Thiotepa: 57.3 minutes. Warning: Do not use with Carmustine.

Source page: https://510kreport.com/device/K192954
Methodology: https://510kreport.com/methodology