510(k) · Cleared
ClearedBrightway Brand Nitrile Examination Gloves 12”, Powder Free, [Purple] Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brightway Holdings Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Apr 21, 2017 as substantially equivalent to K113423 (Kimberly-Clark Corp., 2012) after a 249-day review. Its family tree reaches back 4 generations to 2005.
- Decided
- Apr 21, 2017
- Review
- 249 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K051347 (2005). 10 ancestors in all, the oldest K992062 (1999). No later device cites it as a predicate yet.
- Root · 4 generations backK051347 Kimberly-Clark* Sterling* Nitrile Powder-Free Examination GloveKimberly-Clark Corp. · 2005
- 3 generations backK081260 Kimberly-Clark *Lavender* Nitrile Power-Free Exam GlovesKimberly-Clark Corp. · 2008
- 2 generations backK101596 Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy…Kimberly-Clark · 2010
- 1 generation backK113423 Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free…Kimberly-Clark Corp. · 2012
- This deviceK162294 Brightway Brand Nitrile Examination Gloves 12”, Powder Free…Brightway Holdings Sdn. Bhd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K051347 | Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove | Kimberly-Clark Corp. | 2005 | — |
| −3 | K081260 | Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves | Kimberly-Clark Corp. | 2008 | — |
| −2 | K101596 | Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and… | Kimberly-Clark | 2010 | — |
| −1 | K113423 | Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove | Kimberly-Clark Corp. | 2012 | — |
| 0 (this device) | K162294 | Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Purple] Tested… | Brightway Holdings Sdn. Bhd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZA device
- #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113423 | Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam GloveSummary page 6…eets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250. Predicate Device: Legally Marketed Devices to which Substantial Equivalence is claimed: K113423: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12") Tested for Use with Chemotherapy Drugs 5. Device Descripti… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 2 other devices also cite its predicate K113423.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LZA
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZA
110in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZA
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZA
73in 2025
MAUDE reports naming product code LZA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 95 | 0 | 7 |
| 2008 | 18 | 97 | 0 | 2 |
| 2009 | 28 | 112 | 0 | 12 |
| 2010 | 31 | 97 | 0 | 12 |
| 2011 | 26 | 122 | 0 | 9 |
| 2012 | 33 | 110 | 0 | 11 |
| 2013 | 20 | 130 | 0 | 10 |
| 2014 | 27 | 197 | 0 | 8 |
| 2015 | 20 | 112 | 1 | 12 |
| 2016 | 30 | 171 | 1 | 25 |
| 2017 | 44 | 124 | 0 | 4 |
| 2018 | 22 | 178 | 0 | 3 |
| 2019 | 25 | 212 | 0 | 21 |
| 2020 | 30 | 101 | 0 | 4 |
| 2021 | 139 | 111 | 0 | 20 |
| 2022 | 146 | 111 | 0 | 19 |
| 2023 | 62 | 92 | 0 | 24 |
| 2024 | 30 | 89 | 0 | 76 |
| 2025 | 24 | 110 | 0 | 73 |
| 2026 | 15 | 103 | 3 | — |
What is it indicated for?
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…
Read the full statement (264 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162294: Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Purple] Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162294
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026