510(k) Report

510(k) · Cleared

Cleared

Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

K213937510(k) AbbreviatedCleared Aug 16, 2022243-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 16, 2022 as substantially equivalent to K202622 (O&M Halyard, Inc., 2021) after a 243-day review. Its family tree reaches back 7 generations to 2004.

Decided
Aug 16, 2022
Review
243 days
Class
Class I
Product code
LZA
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K042805 (2004). 8 ancestors in all. No later device cites it as a predicate yet.

  1. Root · 7 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
  2. 6 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
  3. 5 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
  4. 4 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
  5. 3 generations backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
  6. 2 generations backK180646 Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with…Halyard Health · 2018
  7. 1 generation backK202622 Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves…O&M Halyard, Inc. · 2021
  8. This deviceK213937 Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam…O&M Halyard, Inc. · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K042805Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-SterilePerusahaan Getah Asas Sdn. Bhd.2004—
−6K081089Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with…Kimberly-Clark Corp.2008—
−5K141982Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile…Wrp Asia Pacific Sdn. Bhd.2015—
−4K163146POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy DrugsHebei Hongsen Plastics Technology Co, Ltd.2017—
−3K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with…Central Medicare Sdn Bhd2017—
−2K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with…Halyard Health2018—
−1K202622Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for…O&M Halyard, Inc.2021—
0 (this device)K213937Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves…O&M Halyard, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K213937, 2004–2022Source: 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
*K202622Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with…
Summary page 5
…te Device Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs (K202622) Subject Device Description Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves…
O&M Halyard, Inc.2021—

Also cleared against K202622: 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 18 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
  • None of the 8 ancestors has a recall.
  • 1 other device also cites its predicate K202622.

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. 2022, 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 Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution 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, Fentanyl Citrate and Simulated…

Read the full statement (332 words)

Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution 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, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution 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 HCI (2 mg/ml)

Epirubicin HCI (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 HCI (20 mg/ml)

Leuprolide Acetate Salt (5 mg/ml)

Mechlorethamine HCI (1 mg/ml)

Melphalan (5 mg/ml)

Methotrexate (25 mg/ml)

Mitomycin C (0.5 mg/ml)

Mitoxantrone (2 mg/ml)

Oxaliptin (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 60 minutes:

Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes.

Thiotepa (10 mg/ml) No breakthrough up to 30.9 minutes.

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:

Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

Warning: Not for Use With: Carmustine, ThioTEPA

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K213937: Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213937

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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