510(k) · Cleared
ClearedPureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
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 2, 2022 as substantially equivalent to K200633 (0 & M Halyard, Inc., 2020) after a 97-day review. Its family tree reaches back 4 generations to 2005. 1 later device descends from it.
- Decided
- Jun 2, 2022
- Review
- 97 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K051347 (2005). 8 ancestors in all, the oldest K992162 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK051347 Kimberly-Clark* Sterling* Nitrile Powder-Free Examination GloveKimberly-Clark Corp. · 2005
- 3 generations backK081260 Kimberly-Clark *Lavender* Nitrile Power-Free Exam GlovesKimberly-Clark Corp. · 2008
- 2 generations backK101596 Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy…Kimberly-Clark · 2010
- 1 generation backK200633 Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple…0 & M Halyard, Inc. · 2020
- This deviceK220547 PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA…O&M Halyard, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK262014 PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO*…O&M Halyard, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile…O&M Halyard, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K051347 | Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove | Kimberly-Clark Corp. | 2005 | — |
| −3 | K081260 | Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves | Kimberly-Clark Corp. | 2008 | — |
| −2 | K101596 | Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and… | Kimberly-Clark | 2010 | — |
| −1 | K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free… | 0 & M Halyard, Inc. | 2020 | — |
| 0 (this device) | K220547 | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile… | O&M Halyard, Inc. | 2022 | — |
| +1 | K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA*… | O&M Halyard, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile…Summary page 5…ion Glove Predicate Device Halyard Purple Nitrile Powder-Free Exam Glove with Chemotherapy Drug and Fentanyl Citrate Claim (K200633) Subject Device Description The subject device is a dark blue colored, chlorinated, nitrile, powder-free,… | 2020 |
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 |
|---|---|---|---|
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile… | 2026 | 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 17 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K262014 (O&M Halyard, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K200633.
How does its category compare?
All LZA devicesLZA 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
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 PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim is a disposable device 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…
Read the full statement (160 words)
The PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim is a disposable device 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:
Cisplatin (1 mg/ml)
Cyclophosphamide (20 mg/ml)
Dacarbazine (10 mg/ml)
Doxorubicin HCI (2 mg/ml)
Etoposide (20 mg/ml)
Fluorouracil (50 mg/ml)
Ifosfamide (50 mg/ml)
Methotrexate (25 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone HCI (2 mg/ml)
Paclitaxel (6 mg/ml)
Vincrinstine Sulfate (1 mg/ml)
Fentanyl Citrate Injection (100 mcg/2 mL)
Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:
ThioTEPA (10 mg/ml), breakthrough detected at 88.6 minutes
Carmustine (3.3 mg/ml), breakthrough detected at 55.2 minutes
Warning: Not for Use With: Carmustine, ThioTEPA
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220547: PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220547
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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