# K190080: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)

- Pathway: 510(k) (Traditional)
- Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
- Decided: Jun 27, 2019 after 162 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: 5 generations back to K042805 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180476: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, Comfort Rubber Gloves Industries Sdn. Bhd. (2018) Summary page 4.

## Indications for use
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) 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. Tested drugs are as follows: Average Breakthrough Detection Time (minutes) 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 Please note that the following drugs have extremely low permeation time for *Carmustine (BCNU) 3.3mg/ml - 54.1 (mins) *Thiotepa 10.0 mg/ml - 16.0 (mins)

Source page: https://510kreport.com/device/K190080
Methodology: https://510kreport.com/methodology