510(k) · Cleared
ClearedHalyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Halyard Health · LZC Medical Glove, Specialty
Cleared on Jun 27, 2018 as substantially equivalent to K172525 (Central Medicare Sdn Bhd, 2017) after a 107-day review. Its family tree reaches back 5 generations to 2004. 9 later devices descend from it.
- Decided
- Jun 27, 2018
- Review
- 107 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042805 (2004). 6 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 4 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 3 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 2 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 1 generation backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- This deviceK180646 Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with…Halyard Health · 2018
- Descendant · cites it directly · 3 of its ownK191230 Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling…O&M Halyard, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK202622 Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves…O&M Halyard, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK231938 Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK182851 SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with…O&M Halyard, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK243133 Nitrile Powder Free Examination Gloves with Low Dermatitis…Kl-Kepong Rubber Products Sdn. Bhd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile…O&M Halyard, Inc. · 2019 · cites it directly3descendants
- K202622Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with…O&M Halyard, Inc. · 2021 · cites it directly2descendants
- K231938Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for…O&M Halyard, Inc. · 2024 · 2 generations on1descendant
- K182851SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsO&M Halyard, Inc. · 2019 · cites it directly1descendant
- K243133Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use…Kl-Kepong Rubber Products Sdn. Bhd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −4 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −3 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −2 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −1 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| 0 (this device) | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with… | Halyard Health | 2018 | — |
| +1 | K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG*… | O&M Halyard, Inc. | 2019 | — |
| +1 | K202622 | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for… | O&M Halyard, Inc. | 2021 | — |
| +2 | K231938 | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential… | O&M Halyard, Inc. | 2024 | — |
| +1 | K182851 | SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy… | O&M Halyard, Inc. | 2019 | 1 |
| +3 | K243133 | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested… | Kl-Kepong Rubber Products Sdn. Bhd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy…Summary page 4…ice Product Code LZC and Classification Name Class I, 21 CFR §880.6250 Patient Examination Glove Predicate Device K172525 Blue Non-Sterile Powder Free Nitrile Examination Gloves Tested for Use… | 2017 |
| † | K081260 | Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves | 2008 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile… | 2019 | 3 |
| K202622 | Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with… | 2021 | 2 |
| K182851 | SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | 2019 | 1 |
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 14 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K191230 (O&M Halyard, Inc., 2019) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K172525.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The Halyard Lavender Nitrile Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs: Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCl (2.0 mg/ml) No breakthrough up to 240 minutes Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes…
Read the full statement (159 words)
The Halyard Lavender Nitrile Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs:
Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes
Doxorubicin HCl (2.0 mg/ml) No breakthrough up to 240 minutes
Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes
5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes
Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes
Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes
Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes
Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes
Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes
Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes
Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes
ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutes
Warning: Not for Use With : Carmustine, ThioTEPA
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180646: Halyard Lavender Nitrile Powder-Free Exam Glove 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/K180646
Report an extraction error
Are you the manufacturer?
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