510(k) · Cleared
ClearedBrightway Brand Nitrile Examination Gloves 12”, Powder Free, [Sterling/Grey] with Chemotherapy Claim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brightway Holdings Sdn. Bhd. · LZC Medical Glove, Specialty
Cleared on Mar 31, 2017 as substantially equivalent to K081089 (Kimberly-Clark Corp., 2008) after a 239-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- Mar 31, 2017
- Review
- 239 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042805 (2004). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 1 generation backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- This deviceK162186 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 |
|---|---|---|---|---|---|
| −2 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −1 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| 0 (this device) | K162186 | Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Sterling/Grey]… | Brightway Holdings Sdn. Bhd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 LZC? 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 LZC device
- #1 K201390 Medline Powder-Free Light Blue Nitrile Exam…score 19.2 · 5 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 |
|---|---|---|---|
| * | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy…Summary page 6…meets 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: K081089 - Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-EXTRA Powder-Free Exam Gloves with Chemotherapy Drug Use Claim 5. Devi… | 2008 |
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 13 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K081089.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LZC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZC
85in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZC
10in 2025
MAUDE reports naming product code LZC, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 166 | 1 | 0 |
| 2009 | 5 | 253 | 0 | 1 |
| 2010 | 5 | 68 | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 4 | 149 | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 258 | 0 | 5 |
| 2017 | 6 | 121 | 0 | 7 |
| 2018 | 6 | 105 | 0 | 6 |
| 2019 | 7 | 200 | 0 | 8 |
| 2020 | 3 | 167 | 0 | 1 |
| 2021 | 3 | 94 | 1 | 2 |
| 2022 | 7 | 85 | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (167 words)
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.
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/K162186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162186: Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Sterling/Grey] with Chemotherapy Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162186
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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