510(k) · Cleared

Cleared

Kimberly-Clark Lavender Nitrile Power-Free Exam Gloves

K081260510(k) TraditionalCleared Jul 9, 200868-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

Kimberly-Clark Corp. · LZA Polymer Patient Examination Glove

Cleared on Jul 9, 2008 as substantially equivalent to K051347 (Kimberly-Clark Corp., 2005) after a 68-day review. Its family tree reaches back 1 generation to 2005. 16 later devices descend from it.

Decided: Jul 9, 2008
Review: 68 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K051347 (2005). 16 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK051347 Kimberly-Clark* Sterling* Nitrile Powder-Free Examination GloveKimberly-Clark Corp. · 2005
This deviceK081260 Kimberly-Clark *Lavender* Nitrile Power-Free Exam GlovesKimberly-Clark Corp. · 2008
Descendant · cites it directly · 11 of its ownK101596 Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy…Kimberly-Clark · 2010
Descendant · cites it directly · 5 of its ownK153708 Halyard Black-Orange Powder-Free Nitrile Exam GloveHalyard Health · 2016
Descendant · 2 generations on · 5 of its ownK113423 Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free…Kimberly-Clark Corp. · 2012
Descendant · 2 generations on · 4 of its ownK200633 Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple…0 & M Halyard, Inc. · 2020
Descendant · 3 generations on · 2 of its ownK160709 HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2010high 3 (2017) · low 0 (2011)2026

Most influential descendants

Showing 5 of 16 · See all

K101596Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and…Kimberly-Clark · 2010 · cites it directly11descendants
K153708Halyard Black-Orange Powder-Free Nitrile Exam GloveHalyard Health · 2016 · cites it directly5descendants
K113423Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam GloveKimberly-Clark Corp. · 2012 · 2 generations on5descendants
K200633Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile…0 & M Halyard, Inc. · 2020 · 2 generations on4descendants
K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K051347	Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove	Kimberly-Clark Corp.	2005	—
0 (this device)	K081260	Kimberly-Clark Lavender Nitrile Power-Free Exam Gloves	Kimberly-Clark Corp.	2008	—
+1	K101596	Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and…	Kimberly-Clark	2010	—
+1	K153708	Halyard Black-Orange Powder-Free Nitrile Exam Glove	Halyard Health	2016	—
+2	K113423	Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove	Kimberly-Clark Corp.	2012	—
+2	K200633	Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free…	0 & M Halyard, Inc.	2020	—
+3	K160709	HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves	Halyard Health	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2012	1	0
2013	1	0
2015	1	0
2016	2	0
2017	3	0
2018	1	0
2020	1	0
2022	2	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K081260, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K051347	Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove Summary page 1 …lassification Name: Glove, Patient Examination, Poly - 80 LZA Legally marketed device Kimberly-Clark* STERLING* Nitrile Powder-Free Exam Glove - K051347 to which equivalency is claimed: Description of the device: Lavender colored nitrile, chlorinated, powder-free, textured f…	Kimberly-Clark Corp.	2005	—

Also cleared against K051347: 2 other devices →

What descends from it? (16)

See all 16

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K101596	Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and…	Kimberly-Clark	2010	11
K153708	Halyard Black-Orange Powder-Free Nitrile Exam Glove	Halyard Health	2016	5
K162146	Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)	Brightway Holdings Sdn. Bhd.	2017	0
K150113	Fusion Black Powder-Free Nitrile Exam Glove	Halyard Health	2015	0
K131841	Kimberly-Clark Lavender Nitrile Powder-Free Exam Glove	Kimberly-Clark Corp.	2013	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?

Its one ancestor has no recall.
Of its descendants, K101596 (Kimberly-Clark, 2010) has gone furthest, with 11 descendants of its own.
2 other devices also cite its predicate K051347.

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. 2008, this device’s year, is highlighted.

FDA decisions per year · LZA

24in 2025

2007high 146 (2022) · low 18 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZA

110in 2025

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

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

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

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?

Based upon 21CFR§880.6250 "Patient examination glove'

A patient examination glove is a medical 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/K081260 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081260: Kimberly-Clark *Lavender* Nitrile Power-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/K081260

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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

Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves