510(k) Report

510(k) · Cleared

Cleared

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

K243604510(k) AbbreviatedCleared Aug 18, 2025270-day reviewClass I21 CFR 880.6250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

  1. Root · 5 generations backK051347 Kimberly-Clark* Sterling* Nitrile Powder-Free Examination GloveKimberly-Clark Corp. · 2005
  2. 4 generations backK081260 Kimberly-Clark *Lavender* Nitrile Power-Free Exam GlovesKimberly-Clark Corp. · 2008
  3. 3 generations backK101596 Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy…Kimberly-Clark · 2010
  4. 2 generations backK113423 Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free…Kimberly-Clark Corp. · 2012
  5. 1 generation backK160709 HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016
  6. 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

GenerationNumberDeviceApplicantDecidedRecalls
−5K051347Kimberly-Clark* Sterling* Nitrile Powder-Free Examination GloveKimberly-Clark Corp.2005—
−4K081260Kimberly-Clark *Lavender* Nitrile Power-Free Exam GlovesKimberly-Clark Corp.2008—
−3K101596Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and…Kimberly-Clark2010—
−2K113423Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam GloveKimberly-Clark Corp.2012—
−1K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health2016—
0 (this device)K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199920
200410
200820
201010
FIG. 1 — Lineage of K243604, 2005–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves
Summary 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,…
Halyard Health2016—
†K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for…O&M Halyard, Inc.2024—

Also cleared against K160709: 1 other device →

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 devices

LZA 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

2007: 212008: 182009: 282010: 312011: 262012: 332013: 202014: 272015: 202016: 302017: 442018: 222019: 252020: 302021: 1392022: 1462023: 622024: 302025: 242026 (partial year): 15
2007high 146 (2022) · low 18 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZA

110in 2025

2007: 95 days median2008: 97 days median2009: 112 days median2010: 97 days median2011: 122 days median2012: 110 days median2013: 130 days median2014: 197 days median2015: 112 days median2016: 171 days median2017: 124 days median2018: 178 days median2019: 212 days median2020: 101 days median2021: 111 days median2022: 111 days median2023: 92 days median2024: 89 days median2025: 110 days median2026 (partial year): 103 days median
2007high 212 (2019) · low 89 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZA

3so far in 2026, the most since 2007

2015: 12016: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZA

73in 2025

2007: 72008: 22009: 122010: 122011: 92012: 112013: 102014: 82015: 122016: 252017: 42018: 32019: 212020: 42021: 202022: 192023: 242024: 762025: 73
2007high 76 (2024) · low 2 (2008)2025

MAUDE reports naming product code LZA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007219507
2008189702
200928112012
20103197012
20112612209
201233110011
201320130010
20142719708
201520112112
201630171125
20174412404
20182217803
201925212021
20203010104
2021139111020
2022146111019
20236292024
20243089076
202524110073
2026151033—

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.

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