# K200181: Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
- Decided: Apr 15, 2020 after 82 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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
- K220609: Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) (2022), 0 descendants of its own

## Indications for use
The Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical 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. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use chemotherapy drugs and Fentanyl Citrate. Tested chemotherapy drugs are as follows: Cisplatin 1.0 mg/ml ≥ 240 Cyclophosphamide (Cytoxan) 20 mg/ml ≥ 240 Dacarbazine (DTIC) 10.0 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) 3.3mg.ml 54.1 minutes) *Thiotepa 10.0 mg/ml 6.0 (minutes) *Please note that these drugs have extremely low permeation time CAUTION: Testing showed an average breakthrough time of 54.1 minutes with Carmustine. WARNING: Do not use with Thiotepa. Tested Fentanyl Citrate is as follows: Average Breakthrough Detection Time (minutes) Fentanyl Citrate Injection 100.0 mcg/2ml ≥ 240

Source page: https://510kreport.com/device/K200181
Methodology: https://510kreport.com/methodology