# K162294: Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Purple] Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Brightway Holdings Sdn. Bhd.
- Decided: Apr 21, 2017 after 249 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: 4 generations back to K051347 (2005). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113423: Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove, Kimberly-Clark Corp. (2012) Summary page 6.

## Indications for use
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS 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 tested chemotherapy drugs and their breakthrough detection times are as follows: Test Chemotherapy Drug Name and Concentration Minimum Breakthrough Detection Time * Arsenic Trioxide (0.1mg/ml),(100ppm) >240 Minutes * Bleomycin Sulfate (15mg/ml),(15,000 ppm) >240 Minutes * Busulfan(6mg/ml),(6,000 ppm) >240 Minutes * Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) 127.5 Minutes * Cisplatin(1.0mg/ml), (1,000 ppm) >240 Minutes * Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) >240 Minutes * Cytarabine(100mg/ml), (100,000 ppm) >240 Minutes * Dacarbazine(DTIC) 1Omg/ml, (10,000 ppm) >240 Minutes * Daunorubicin(5mg/ml), (5,000 ppm) >240 Minutes * Docetaxel(10mg/ml), (10,000 ppm) >240 Minutes * Doxorubicin HCL(2mg/ml),(2,000 ppm) >240 Minutes * Ellence (2mg/ml), (2,000 ppm) >240 Minutes * Etoposide /Toposar (20mg/ml), (20,000 ppm) >240 Minutes * Fludarabine (25mg/ml), (25,000 ppm) >240 Minutes * Fluorouracil(50mg/ml), (50,000 ppm) >240 Minutes * Gemcitabine/Gemzar (38mg/ml), (38,000 ppm) >240 Minutes * Idarubicin(1.Omg/ml), (1,000 ppm) >240 Minutes * Ifosfamide (50mg/ml), (50,000 ppm) >240 Minutes * Irinotecan(20mg/ml), (20,000 ppm) >240 Minutes * Mechlorethamine HCI(1.0mg/ml), (1,000 ppm) >240 Minutes * Melphalan(5mg/ml), (5,000 ppm) >240 Minutes * Methotrexate(25mg/ml),(25,000 ppm) >240 Minutes * Mitomycin C(0.5 mg/ml), (500 ppm) >240 Minutes * Mitoxantrone(2mg/ml),(2,000 ppm) >240 Minutes * Paclitaxel(6.Omg/ml),(6,000 ppm) >240 Minutes * Paraplatin (10mg/ml),(10,000 ppm) >240 Minutes * Rituximab(10mg/ml),(10,000 ppm) >240 Minutes * Thiotepa (10mg/ml),(10,000 ppm) >240 Minutes * Trisenox(0.lmg/ml), (100 ppm) >240 Minutes * Vincristine Sulfate(1.Omg/ml),(1,000 ppm) >240 Minutes Please note that the following drug noted permeation times below 240 mins: Carmustine (BCNU) 127.50 mins.

Source page: https://510kreport.com/device/K162294
Methodology: https://510kreport.com/methodology