510(k) · Cleared
ClearedHalyard Purple Nitrile, Powder-Free Exam Gloves 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 Aug 1, 2022 as substantially equivalent to K200633 (0 & M Halyard, Inc., 2020) after a 228-day review. Its family tree reaches back 4 generations to 2005. 1 later device descends from it.
- Decided
- Aug 1, 2022
- Review
- 228 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K051347 (2005). 8 ancestors in all, the oldest K992162 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK051347 Kimberly-Clark* Sterling* Nitrile Powder-Free Examination GloveKimberly-Clark Corp. · 2005
- 3 generations backK081260 Kimberly-Clark *Lavender* Nitrile Power-Free Exam GlovesKimberly-Clark Corp. · 2008
- 2 generations backK101596 Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy…Kimberly-Clark · 2010
- 1 generation backK200633 Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple…0 & M Halyard, Inc. · 2020
- This deviceK213929 Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with…O&M Halyard, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK241909 Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for…O&M Halyard, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K051347 | Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove | Kimberly-Clark Corp. | 2005 | — |
| −3 | K081260 | Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves | Kimberly-Clark Corp. | 2008 | — |
| −2 | K101596 | Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and… | Kimberly-Clark | 2010 | — |
| −1 | K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free… | 0 & M Halyard, Inc. | 2020 | — |
| 0 (this device) | K213929 | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with… | O&M Halyard, Inc. | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile…Summary page 5…e With Chemotherapy Drugs Predicate Device Halyard Purple , Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs (K200633) Subject Device Description The Halyard Purple Powder-Free Nitrile Exam Glove tested with… | 2020 |
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 |
|---|---|---|---|
| K241909 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for… | 2024 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K241909 (O&M Halyard, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K200633.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Halyard Purple Nitrile, Powder-Free Exam Gloves are disposable devices 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 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)…
Read the full statement (301 words)
The Halyard Purple Nitrile, Powder-Free Exam Gloves are disposable devices 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 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 HCl (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 HCl (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 HCl (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
No breakthrough was detected up to 240 minutes for Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213929 · printed Nov 3, 2026
Cite this page
510(k) Report. “K213929: Halyard Purple Nitrile, Powder-Free Exam Gloves 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 3, 2026. https://510kreport.com/device/K213929
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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