# K161215: Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Brightway Holdings Sdn. Bhd.
- Decided: Dec 21, 2016 after 236 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: 2 generations back to K090412 (2009). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151750: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Kossan International Sdn Bhd (2016). Cleared while this submission was under review Summary page 7.

## Most influential descendants
- K171104: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) (2017), 0 descendants of its own

## Indications for use
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs and their breakthrough detection times are as follows: Test Chemotherapy Drug Name and Concentration Minimum Breakthrough Detection Time » Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) 5.4 Minutes * Cisplatin(1.0mg/ml), (1,000 ppm) >240 Minutes * Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) >240 Minutes * Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) >240 Minutes * Doxorubicin HCL(2mg/ml),(2,000 ppm) >240 Minutes * Etoposide /Toposar (20mg/ml), (20,000 ppm) >240 Minutes ¢ Fluorouracil(50mg/ml), (50,000 ppm) >240 Minutes * Ifosfamide (50mg/ml), (50,000 ppm) >240 Minutes » Mitoxantrone(2mg/ml),(2,000 ppm) >240 Minutes » Paclitaxel/Taxol(6.0mg/ml),(6,000 ppm) >240 Minutes * Thiotepa (10mg/ml),(10,000 ppm) 40.4 Minutes * Vincristine Sulfate(1.0mg/ml),(1,000 ppm) >240 Minutes Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 5.4 minutes and Thiotepa 40.4 minutes.

Source page: https://510kreport.com/device/K161215
Methodology: https://510kreport.com/methodology