510(k) Report

510(k) · Cleared

Cleared

Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles

K243172510(k) AbbreviatedCleared Jun 18, 2025261-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 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.

  1. Root · 3 generations backK992062 Safeskin Sterile Purple Nitrile Examination GlovesSafeskin Corp. · 1999
  2. 2 generations backK081027 Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)Kimberly-Clark Corp. · 2008 · Recalled
  3. 1 generation backK102032 Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove…Kimberly-Clark Corp. · 2010
  4. 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

GenerationNumberDeviceApplicantDecidedRecalls
−3K992062Safeskin Sterile Purple Nitrile Examination GlovesSafeskin Corp.1999—
−2K081027Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)Kimberly-Clark Corp.20081
−1K102032Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove…Kimberly-Clark Corp.2010—
0 (this device)K243172Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple…O&M Halyard, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200410
200510
200810
FIG. 1 — Lineage of K243172, 1999–2025Source: 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
*K102032Kimberly-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…
Kimberly-Clark Corp.2010—
†K213929Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs…O&M Halyard, Inc.2022—

Also cleared against K102032: 2 other devices →

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 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?

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.

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