510(k) · Cleared
ClearedHalyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid
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 Aug 18, 2025 as substantially equivalent to K160709 (Halyard Health, 2016) after a 270-day review. Its family tree reaches back 5 generations to 2005.
- Decided
- Aug 18, 2025
- Review
- 270 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K051347 (2005). 11 ancestors in all, the oldest K992062 (1999). No later device cites it as a predicate yet.
- Root · 5 generations backK051347 Kimberly-Clark* Sterling* Nitrile Powder-Free Examination GloveKimberly-Clark Corp. · 2005
- 4 generations backK081260 Kimberly-Clark *Lavender* Nitrile Power-Free Exam GlovesKimberly-Clark Corp. · 2008
- 3 generations backK101596 Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy…Kimberly-Clark · 2010
- 2 generations backK113423 Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free…Kimberly-Clark Corp. · 2012
- 1 generation backK160709 HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016
- This deviceK243604 Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K051347 | Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove | Kimberly-Clark Corp. | 2005 | — |
| −4 | K081260 | Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves | Kimberly-Clark Corp. | 2008 | — |
| −3 | K101596 | Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and… | Kimberly-Clark | 2010 | — |
| −2 | K113423 | Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove | Kimberly-Clark Corp. | 2012 | — |
| −1 | K160709 | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves | Halyard Health | 2016 | — |
| 0 (this device) | K243604 | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis… | O&M Halyard, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K160709 | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesSummary page 6…QDO Class I, 21 CFR §880.6250 Fentanyl and Other Opioid Protection Glove Predicate Device HALYARD* PURPLE NITRILE - XTRA* Powder Free-Exam Gloves (K160709) Reference Device Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential,… | 2016 |
| † | K241909 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for… | 2024 |
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 20 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 1 other device also cites its predicate K160709.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Arsenic Trioxide (1 mg/ml)…
Read the full statement (290 words)
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Arsenic Trioxide (1 mg/ml)
Bendamustine, (5 mg/ml)
Blenoxane (15 mg/ml)
Bleomycin (15 mg/ml)
Bortezomib (1 mg/ml)
Busulfan (6 mg/ml)
Carboplatln (10 mg/ml)
Carfilzomib (2 mg/ml)
Cetuximab (2 mg/ml)
Cisplatin (1 mg/ml)
Cyclophosphamide (Cytoxan) (20 mg/ml)
Cytarabine (100 mg/ml)
Dacarbazine (DTIC) {10 mg/ml)
Daunorubicin {5 mg/ml)
Decitabine (5 mg/ml)
Docetaxel (10 mg/ml)
Doxorubicin HCL (2 mg/ml)
Ellence (2 mg/ml)
Erbitux (2 mg/ml)
Eribilin Mesylate (0.5 mg/ml)
Etoposide (Toposar) (20 mg/ml)
Fludarabine (25 mg/ml)
Fulvestrant (50 mg/ml)
Gemcitabine (Gemzar) (38 mg/ml)
ldarubicin (1 mg/ml)
Ifosfamide (IFEX) (50 mg/ml)
Irinotecan (20 mg/ml)
Mechlorethamine HCL (1 mg/ml)
Melphalan (5 mg/ml)
Methotrexate (25 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone (2 mg/ml)
Oxaliplatin (2 mg/ml)
Paclitaxel (Taxol) (6 mg/ml)
Paraplatin (10 mg/ml)
Pemetrexed Disodium (25 mg/ml)
Pertuzumab (30 mg/ml)
Raltitrexed (0.5 mg/ml)
Rituximab (Rituxan) (10 mg/ml)
Temsirolimus (25 mg/ml)
Thiotepa (10 mg/ml)
Topotecan HCL (1 mg/ml)
Trastuzumab (21 mg/ml)
Trisenox (1 mg/ml)
Velcade (1 mg/ml)
Vinblastine (1 mg/ml)
Vinorelbine (10 mg/ml)
Carmustine (3.3 mg/ml) permeation occurred at 60.0 minutes.
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
Fentanyl Citrate Injection (100 mcg/2 ml)
Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution)
Caution: Testing showed a minimum breakthrough time of 60.0 minutes with Carmustine.
The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:
Cytovene (10 mg/ml)
Retrovir (10 mg/ml)
Triclosan (2 mg/ml)
Zoledronic Acid (0.8 mg/ml)
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/K243604 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243604: Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243604
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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