510(k) · Cleared
ClearedHalyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O&M Halyard, Inc. · LZC Medical Glove, Specialty
Cleared on Feb 5, 2019 as substantially equivalent to K081089 (Kimberly-Clark Corp., 2008) after an 84-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Feb 5, 2019
- Review
- 84 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042805 (2004). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 1 generation backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- This deviceK183132 Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for…O&M Halyard, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK200843 Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested…O&M Halyard, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200843Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy…O&M Halyard, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −1 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| 0 (this device) | K183132 | Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with… | O&M Halyard, Inc. | 2019 | — |
| +1 | K200843 | Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with… | O&M Halyard, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 LZC? 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 LZC device
- #1 K201390 Medline Powder-Free Light Blue Nitrile Exam…score 19.2 · 5 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 |
|---|---|---|---|
| * | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy…Summary page 5…roduct Code and LZA, LZC Classification Name Class I, 21 CFR §880.6250 Patient Examination Glove Predicate Device K081089 Halyard Sterling Nitrile-Xtra Powder-Free Exam Gloves Tested for Use with… | 2008 |
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 |
|---|---|---|---|
| K200843 | Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy… | 2020 | 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 15 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K200843 (O&M Halyard, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K081089.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LZC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZC
85in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZC
10in 2025
MAUDE reports naming product code LZC, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 166 | 1 | 0 |
| 2009 | 5 | 253 | 0 | 1 |
| 2010 | 5 | 68 | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 4 | 149 | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 258 | 0 | 5 |
| 2017 | 6 | 121 | 0 | 7 |
| 2018 | 6 | 105 | 0 | 6 |
| 2019 | 7 | 200 | 0 | 8 |
| 2020 | 3 | 167 | 0 | 1 |
| 2021 | 3 | 94 | 1 | 2 |
| 2022 | 7 | 85 | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Halyard Pink Underguard Nitrile Powder-Free Exam Glove is a disposable device 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: • Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes • Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes • Bendamustine (5 mg/ml) No breakthrough up to 240…
Read the full statement (589 words)
The Halyard Pink Underguard Nitrile Powder-Free Exam Glove is a disposable device 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:
• Arsenic Trioxide (1 mg/ml) No breakthrough up to 240 minutes
• Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes
• Bendamustine (5 mg/ml) No breakthrough up to 240 minutes
• Bortezomib (Velcade) (1 mg/ml) No breakthrough up to 240 minutes
• Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes
• Busulfan (6 mg/ml) No breakthrough up to 240 minutes
• Carboplatin (10 mg/ml) No breakthrough up to 240 minutes
• Car¬filzomib (2 mg/ml) No breakthrough up to 240 minutes
• Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes
• Cisplatin (1 mg/ml) No breakthrough up to 240 minutes
• Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes
• Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes
• Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes
• Cytovene (10 mg/ml) No breakthrough up to 240 minutes
• Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes
• Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes
• Decitabine (5 mg/ml) No breakthrough up to 240 minutes
• Docetaxel (10 mg/ml) No breakthrough up to 240 minutes
• Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes
• Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes
• Etoposide (20 mg/ml) No breakthrough up to 240 minutes
• Fludarabine (25 mg/ml) No breakthrough up to 240 minutes
• Fluorouracil (50 mg/ml) No breakthrough up to 240 minutes
• Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes
• Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes
• Idarubicin (1 mg/ml) No breakthrough up to 240 minutes
• Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes
• Irinotecan (20 mg/ml) No breakthrough up to 240 minutes
• Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes
• Melphalan (5 mg/ml) No breakthrough up to 240 minutes
• Methotrexate (25 mg/ml) No breakthrough up to 240 minutes
• Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes
• Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes
• Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes
• Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes
• Paraplatin (10 mg/ml) No breakthrough up to 240 minutes
• Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes
• Pertuzumab (30 mg/ml) No breakthrough up to 240 minutes
• Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes
• Retrovir (10 mg/ml) No breakthrough up to 240 minutes
• Rituximab (10 mg/ml) No breakthrough up to 240 minutes
• Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes
• Trastuzumab (21 mg/ml) No breakthrough up to 240 minutes
• Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes
• Triclosan (2 mg/ml) No breakthrough up to 240 minutes
• Trisonex (1.0 mg/ml) No breakthrough up to 240 minutes
• Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes
• Vinblastine (1 mg/ml) No breakthrough up to 240 minutes
• Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes
• Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes
CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 240 minutes:
• Carmustine (3.3 mg/ml) No breakthrough up to 54.7 minutes
• ThioTEPA (10 mg/ml) No breakthrough up to 128.5 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183132: Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183132
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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