510(k) · Cleared
Recalled · Class II · 2021SkyBreeze Zero 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
O&M Halyard, Inc. · LZA Polymer Patient Examination Glove
Cleared on Jun 26, 2019 as substantially equivalent to K180646 (Halyard Health, 2018) after a 259-day review. Its family tree reaches back 6 generations to 2004. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 26, 2019
- Review
- 259 days
- Class
- Class I
- Product code
- LZA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K042805 (2004). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 5 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 4 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 3 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 2 generations backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- 1 generation backK180646 Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with…Halyard Health · 2018
- This deviceK182851 SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with…O&M Halyard, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK220118 Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder…Kl-Kepong Rubber Products Sdn. Bhd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220118Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination…Kl-Kepong Rubber Products Sdn. Bhd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −5 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −4 | K141982 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile… | Wrp Asia Pacific Sdn. Bhd. | 2015 | — |
| −3 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs | Hebei Hongsen Plastics Technology Co, Ltd. | 2017 | — |
| −2 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| −1 | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with… | Halyard Health | 2018 | — |
| 0 (this device) | K182851 | SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy… | O&M Halyard, Inc. | 2019 | — |
| +1 | K220118 | Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free… | Kl-Kepong Rubber Products Sdn. Bhd. | 2022 | — |
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 |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsSummary page 4…LZA, LZC and Classification Name Class I, 21 CFR §880.6250 Patient Examination Glove Predicate Device K180646 Halyard Lavender Nitrile Powder-Free Exam Gloves Tested for Use… | 2018 |
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 |
|---|---|---|---|
| K220118 | Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination… | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2021 | Class II | Z-0317-2022 | Component design/selection | All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K220118 (Kl-Kepong Rubber Products Sdn. Bhd., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K180646.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The Skybreeze Zero 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: Tested Chemotherapy Drugs and Concentration Average Breakthrough Detection Time (Minutes) • Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes • Doxorubicin HCl (2.0 mg/ml) No…
Read the full statement (180 words)
The Skybreeze Zero 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:
Tested Chemotherapy Drugs and Concentration Average Breakthrough Detection Time (Minutes)
• 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 18.6 minutes
• ThioTEPA (10.0 mg.ml) No breakthrough up to 48.3 minutes
Warning: Not for Use with: Carmustine, ThioTEPA
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182851: SkyBreeze Zero 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/K182851
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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