510(k) · Cleared
ClearedHalyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles
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 18, 2025 as substantially equivalent to K102032 (Kimberly-Clark Corp., 2010) after a 261-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Jun 18, 2025
- Review
- 261 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K992062 (1999). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK992062 Safeskin Sterile Purple Nitrile Examination GlovesSafeskin Corp. · 1999
- 2 generations backK081027 Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)Kimberly-Clark Corp. · 2008 · Recalled
- 1 generation backK102032 Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove…Kimberly-Clark Corp. · 2010
- This deviceK243172 Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs…O&M Halyard, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K992062 | Safeskin Sterile Purple Nitrile Examination Gloves | Safeskin Corp. | 1999 | — |
| −2 | K081027 | Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile) | Kimberly-Clark Corp. | 2008 | 1 |
| −1 | K102032 | Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove… | Kimberly-Clark Corp. | 2010 | — |
| 0 (this device) | K243172 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple… | O&M Halyard, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K102032 | Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove)…Summary page 6…Device Kimberly‐Clark Purple Nitrile XTRA* Sterile Powder‐Free Exam Glove (Chemotherapy Glove) ‐ 12 Sterile Pairs (K102032) Reference Devices Halyard Purple Nitrile, Powder‐Free Exam Gloves Tested for Use with… | 2010 |
| † | K213929 | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs… | 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 26 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 2 other devices also cite its predicate K102032.
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?
The Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs or Sterile Singles, 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 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…
Read the full statement (323 words)
The Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs or Sterile Singles, 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 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:
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)
Carfilzomib (2 mg/ml)
Cetuximab (2 mg/ml)
Cisplatin (1 mg/ml)
Cladribine (1 mg/ml)
Cyclophosphamide (20 mg/ml)
Cytarabine HCI (100 mg/ml)
Dacarbazine (10 mg/ml)
Dactinomycin (0.5 mg/ml)
Daunorubicin HCI (5 mg/ml)
Decitabine (5 mg/ml)
Docetaxel (10 mg/ml)
Doxorubicin HCI (2 mg/ml)
Epirubicin HCI (2 mg/ml)
Etoposide (20 mg/ml)
Fludarabine Phosphate (25 mg/ml)
Fluorouracil (50 mg/ml)
Fulvestrant (50 mg/ml)
Gemcitabine HCI (38 mg/ml)
Idarubicin HCI (1 mg/ml)
Ifosfamide (50 mg/ml)
Irinotecan HCI (20 mg/ml)
Leuprolide Acetate (5 mg/ml)
Mechlorethamine HCI (1 mg/ml)
Melphalan HCI (5 mg/ml)
Methotrexate (25 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone HCI (2 mg/ml)
Oxaliplatin (5 mg/ml)
Paclitaxel (6 mg/ml)
Pemetrexed (25 mg/ml)
Raltitrexed (0.5 mg/ml)
Rituximab (10 mg/ml)
Temsirolimus (25 mg/ml)
Topotecan HCI (1 mg/ml)
Trisenox (Arsenic Trioxide) (1 mg/ml)
Vinblastine Sulfate (1 mg/ml)
Vincristine (1 mg/ml)
Vinorelbine Tartrate (10 mg/ml)
The following chemotherapy drugs and concentration showed breakthrough detected in less than 100 minutes:
Carmustine (3.3 mg/ml) No breakthrough up to 44.5 minutes.
Thiotepa (10 mg/ml) No breakthrough up to 99.1 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
The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:
Chloroquine (50 mg/ml)
Cyclosporin A (100 mg/ml)
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/K243172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243172: Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243172
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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