510(k) · Cleared
ClearedBrightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] 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 Dec 21, 2016 as substantially equivalent to K151750 (Kossan International Sdn Bhd, 2016) after a 236-day review. Its family tree reaches back 2 generations to 2009. 1 later device descends from it.
- Decided
- Dec 21, 2016
- Review
- 236 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K090412 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK090412 Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White).Gx Corporation Sdn Bhd · 2009
- 1 generation backK151750 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2016
- This deviceK161215 Brightway Brand Nitrile Examination Gloves, Powder Free…Brightway Holdings Sdn. Bhd. · 2016
- Descendant · cites it directly · 0 of its ownK171104 Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use…Yty Industry (Manjung) Sdn Bhd · 2017
Most influential descendants
Showing 1 of 1 · See all- K171104Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy…Yty Industry (Manjung) Sdn Bhd · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K090412 | Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White). | Gx Corporation Sdn Bhd | 2009 | — |
| −1 | K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2016 | — |
| 0 (this device) | K161215 | Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey]… | Brightway Holdings Sdn. Bhd. | 2016 | — |
| +1 | K171104 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with… | Yty Industry (Manjung) Sdn Bhd | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free… Cleared while this submission was under review Summary page 7…ev3 8. Legally Marketed Device to which Substantial Equivalence is Claimed The legally marketed predicate device in scope is as follows: 1) K151750 - Powder Free Nitrile Patient Examination Glove, Blue Colored, Non- Sterile, Powder Free Nitrile Patient Examinati… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171104 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy… | 2017 | 0 |
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 7 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K171104 (Yty Industry (Manjung) Sdn Bhd, 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K151750.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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, 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)…
Read the full statement (152 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161215: Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] 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/K161215
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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