510(k) · Cleared
ClearedKimberly-Clark Lavender Nitrile Powder-Free Exam Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corp. · LZA Polymer Patient Examination Glove
Cleared on Nov 7, 2013 as substantially equivalent to K081260 (Kimberly-Clark Corp., 2008) and 1 other predicate after a 139-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Nov 7, 2013
- Review
- 139 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K051347 (2005). 3 ancestors in all, the oldest K992830 (1999). No later device cites it as a predicate yet.
- 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 deviceK131841 Kimberly-Clark Lavender Nitrile Powder-Free Exam GloveKimberly-Clark Corp. · 2013
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) | K131841 | Kimberly-Clark Lavender Nitrile Powder-Free Exam Glove | Kimberly-Clark Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (2)
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 1…Patient examination'glove. Device Classification Class I per 21 CFR §880.6250 and Product Code Product Code - LZA PRLEDICATE DEVICES: K08 1260 - KlMBERLY-CLAR-K* LAVENDER* NITRILE Powder-Free Exam Gloves K992830 - Safeskin Polymer-Coated Nitrile Examination Gloves SUBST… | 2008 |
| * | K992830 | Safeskin Polymer-Coated Nitrile Examination Gloves, Powder-Free Shieldmaster Nitrile GloveSummary page 1…ss I per 21 CFR §880.6250 and Product Code Product Code - LZA PRLEDICATE DEVICES: K08 1260 - KlMBERLY-CLAR-K* LAVENDER* NITRILE Powder-Free Exam Gloves K992830 - Safeskin Polymer-Coated Nitrile Examination Gloves SUBSTANTIAL EQUIVALENCE: The subject KIMBERLY-CLARK* LAVENDER* NITRILE Powd… | 1999 |
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 8 years and passes through 1 company; a new generation was cleared every 5.3 years on median.
- None of the 3 ancestors has a recall.
- 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. 2013, 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?
KIMBERLY-CLARK LAVENDER NITRILE Powder-Free Exam Gloves are disposable devices intended for medical purposes that are 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/K131841 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131841: Kimberly-Clark Lavender Nitrile Powder-Free Exam Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131841
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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