510(k) · Cleared
ClearedHalyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl 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 Sep 27, 2024 as substantially equivalent to K213929 (O&M Halyard, Inc., 2022) after an 88-day review. Its family tree reaches back 5 generations to 2005.
- Decided
- Sep 27, 2024
- Review
- 88 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K051347 (2005). 9 ancestors in all, the oldest K992162 (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 backK200633 Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple…0 & M Halyard, Inc. · 2020
- 1 generation backK213929 Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with…O&M Halyard, Inc. · 2022
- This deviceK241909 Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc. · 2024
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 | K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free… | 0 & M Halyard, Inc. | 2020 | — |
| −1 | K213929 | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with… | O&M Halyard, Inc. | 2022 | — |
| 0 (this device) | K241909 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential… | O&M Halyard, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K213929 | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs…Summary page 6…Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K213929) Reference Device Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves… | 2022 |
| † | K213937 | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for… | 2022 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate and Gastric Acid as per…
Read the full statement (327 words)
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate and Gastric Acid as per ASTM -D6978-05:
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Azacitidine (25 mg/ml)
Bendamustine HCI (5 mg/ml)
Bleomycin Sulfate (15 mg/ml)
Bortezomib (1 mg/ml)
Busulfan (6 mg/ml)
Capecitabine (26 mg/ml)
Carboplatin (10 mg/ml)
Carlzomib (2 mg/ml)
Cetuximab (2 mg/ml)
Chloroquine (50 mg/ml)
Cisplatin (1 mg/ml)
Cladribine (1 mg/ml)
Cyclophosphamide (20 mg/ml)
Cyclosporin A (100 mg/ml)
Cytarabine (Cytosine) (100 mg/ml)
Cytovene (Ganciclovir) (10 mg/ml)
Dacarbazine (DTIC) (10 mg/ml)
Dactinomycin (0.5 mg/ml)
Daunorubicin HCI (5 mg/ml)
Decitabine (5 mg/ml)
Docetaxel (10 mg/ml)
Doxorubicin HCl (2 mg/ml)
Epirubicin HCl (Ellence) (2 mg/ml)
Etoposide (Toposar) (20 mg/ml)
Fludarabine (25 mg/ml)
5-Fluorouracil (50 mg/ml)
Fulvestrant (50 mg/ml)
Gemcitabine (38 mg/ml)
Idarubicin (1 mg/ml)
Ifosfamide (50 mg/ml)
Irinotecan HCl (20 mg/ml)
Leuprolide Acetate Salt (5 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 (5 mg/ml)
Paclitaxel (6 mg/ml)
Pemetrexed (25 mg/ml)
Raltitrexed (0.5 mg/ml)
Retrovir (10 mg/ml)
Rituximab (10 mg/ml)
Temsirolimus (25 mg/ml)
Topotecan HCI (1 mg/ml)
Triclosan (2 mg/ml)
Trisenox (1 mg/ml)
Vinblastine Sulfate (1 mg/ml)
Vincristine (1 mg/ml)
Vinorelbine (10 mg/ml)
Zoledronic Acid (0.8 mg/ml)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes.
Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes.
Warning- Not for use with Carmustine and ThioTEPA
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
Fentanyl Citrate Injection (100 mcg/2 ml)
Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution) (50 mcg/2 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/K241909 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241909: Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241909
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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