# K162186: Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Sterling/Grey] with Chemotherapy Claim

- Pathway: 510(k) (Traditional)
- Applicant: Brightway Holdings Sdn. Bhd.
- Decided: Mar 31, 2017 after 239 days
- Product code: LZC (Medical Glove, Specialty)
- 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 K042805 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081089: Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim, Kimberly-Clark Corp. (2008) Summary page 6.

## Indications for use
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”7, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner. The product has been tested with chemotherapy drugs in accordance with ASTM D6978. The breakthrough detection times are as follows: Test Chemotherapy Drug Name and Concentration Minimum Breakthrough Detection Time » Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) 4.3 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(6.0mg/ml),(6,000 ppm) >240 Minutes * Thiotepa (10mg/ml),(10,000 ppm) 10.9 Minutes * Vincristine Sulfate(1.0mg/ml),(1,000 ppm) >240 Minutes Please note that Carmustine and Thiotepa have extremely low permeation times of 4.3 minutes and 10.9 minutes, respectively. Warning: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K162186
Methodology: https://510kreport.com/methodology