# K162405: Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.
- Decided: Mar 28, 2017 after 211 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 K042805 (2004). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141982: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs, Wrp Asia Pacific Sdn. Bhd. (2015) Summary page 5.

## Most influential descendants
- K180476: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (2018), 1 descendant of its own
- K190080: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) (2019), 0 descendants of its own

## Indications for use
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (White) 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 with chemotherapy drugs. Tested chemotherapy drugs are as follows: Average Breakthrough Detection Time (minutes) Cisplatin, 1.0 mg/ml > 240 Cyclophosphamide (Cytoxan), 20.0 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 24.0 (mins) Thiotepa 10.0 mg/ml 54.9 (mins) Please note that the following drugs have extremely low permeation time for: Carmustine (BCNU) 3.3mg/ml - 24.0 (mins) Thiotepa 10.0 mg/ml - 54.9 (mins) The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) 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 with chemotherapy drugs. Tested chemotherapy drugs are as follows: Average Breakthrough Detection Time (minutes) Cisplatin, 1.0 mg/ml =240 Cyclophosphamide (Cytoxan), 20.0 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 18.2 (mins) Thiotepa 10.0 mg/ml 57.3 (mins) Please note that the following drugs have extremely low permeation time for: Carmustine (BCNU) 3.3mg/ml - 18.2 (mins) Thiotepa 10.0 mg/ml - 57.3 (mins)

Source page: https://510kreport.com/device/K162405
Methodology: https://510kreport.com/methodology