510(k) · Cleared
ClearedHalyard Black-Orange Powder-Free Nitrile Exam Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Halyard Health · LZA Polymer Patient Examination Glove
Cleared on Mar 31, 2016 as substantially equivalent to K081260 (Kimberly-Clark Corp., 2008) after a 99-day review. Its family tree reaches back 2 generations to 2005. 5 later devices descend from it.
- Decided
- Mar 31, 2016
- Review
- 99 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051347 (2005). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK051347 Kimberly-Clark* Sterling* Nitrile Powder-Free Examination GloveKimberly-Clark Corp. · 2005
- 1 generation backK081260 Kimberly-Clark *Lavender* Nitrile Power-Free Exam GlovesKimberly-Clark Corp. · 2008
- This deviceK153708 Halyard Black-Orange Powder-Free Nitrile Exam GloveHalyard Health · 2016
- Descendant · cites it directly · 4 of its ownK200633 Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple…0 & M Halyard, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK213929 Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with…O&M Halyard, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK220547 PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA…O&M Halyard, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK262014 PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO*…O&M Halyard, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK241909 Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K200633Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile…0 & M Halyard, Inc. · 2020 · cites it directly4descendants
- K213929Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs…O&M Halyard, Inc. · 2022 · 2 generations on1descendant
- K220547PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free…O&M Halyard, Inc. · 2022 · 2 generations on1descendant
- K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile…O&M Halyard, Inc. · 2026 · 3 generations on0descendants
- K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for…O&M Halyard, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051347 | Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove | Kimberly-Clark Corp. | 2005 | — |
| −1 | K081260 | Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves | Kimberly-Clark Corp. | 2008 | — |
| 0 (this device) | K153708 | Halyard Black-Orange Powder-Free Nitrile Exam Glove | Halyard Health | 2016 | — |
| +1 | K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free… | 0 & M Halyard, Inc. | 2020 | — |
| +2 | K213929 | Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with… | O&M Halyard, Inc. | 2022 | — |
| +2 | K220547 | PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile… | O&M Halyard, Inc. | 2022 | — |
| +3 | K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA*… | O&M Halyard, Inc. | 2026 | — |
| +3 | K241909 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential… | O&M Halyard, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K081260 | Kimberly-Clark *Lavender* Nitrile Power-Free Exam GlovesSummary page 4…ation Name: Class I, 21 CFR §880.6250 Patient Examination Glove Predicate Device: K081260 Kimberly-Clark Lavender Nitrile Powder-Free Exam Gloves Subject Device Description… | 2008 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile… | 2020 | 4 |
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 11 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K200633 (0 & M Halyard, Inc., 2020) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K081260.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Halyard Black-Orange Powder-Free Nitrile 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153708: Halyard Black-Orange Powder-Free Nitrile Exam Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153708
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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