510(k) · Cleared

Recalled · Class II · 2016

Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)

K081027510(k) AbbreviatedCleared Jun 30, 200881-day reviewClass I21 CFR 880.6250Recalls 1

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 Jun 30, 2008 as substantially equivalent to K051347 (Kimberly-Clark Corp., 2005) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 1999. 9 later devices descend from it. It has been recalled once.

Decided: Jun 30, 2008
Review: 81 days
Class: Class I
Product code: LZA
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K992062 (1999). 2 ancestors in all. 9 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK992062 Safeskin Sterile Purple Nitrile Examination GlovesSafeskin Corp. · 1999
This deviceK081027 Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)Kimberly-Clark Corp. · 2008
Descendant · cites it directly · 8 of its ownK102032 Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove…Kimberly-Clark Corp. · 2010
Descendant · 2 generations on · 5 of its ownK113423 Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free…Kimberly-Clark Corp. · 2012
Descendant · 3 generations on · 2 of its ownK160709 HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016
Descendant · 4 generations on · 0 of its ownK243604 Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis…O&M Halyard, Inc. · 2025
Descendant · 2 generations on · 0 of its ownK243172 Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs…O&M Halyard, Inc. · 2025

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2010high 2 (2017) · low 0 (2011)2026

Most influential descendants

Showing 5 of 9 · See all

K102032Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove)…Kimberly-Clark Corp. · 2010 · cites it directly8descendants
K113423Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam GloveKimberly-Clark Corp. · 2012 · 2 generations on5descendants
K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016 · 3 generations on2descendants
K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested…O&M Halyard, Inc. · 2025 · 4 generations on0descendants
K243172Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile*…O&M Halyard, Inc. · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K992062	Safeskin Sterile Purple Nitrile Examination Gloves	Safeskin Corp.	1999	—
0 (this device)	K081027	Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)	Kimberly-Clark Corp.	2008	—
+1	K102032	Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove…	Kimberly-Clark Corp.	2010	—
+2	K113423	Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove	Kimberly-Clark Corp.	2012	—
+3	K160709	HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves	Halyard Health	2016	—
+4	K243604	Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis…	O&M Halyard, Inc.	2025	—
+2	K243172	Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple…	O&M Halyard, Inc.	2025	—

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
2010	1	0
2012	1	0
2016	1	0
2017	2	0
2018	1	0
2020	1	0
2025	2	0

FIG. 1 — Lineage of K081027, 1999–2025Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K051347	Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove Summary page 1 …fication Name: Glove, Patient Examination, Poly - 80 LZA Legally marketed device · Kimberly-Clark* STERLING* Nitrile Powder-Free Exam Glove (K051347) to which equivalency is · Kimberly-Clark* PURPLE NITRILE* Powder-Free Exam Glove, Sterile claimed:…	Kimberly-Clark Corp.	2005	—
*	K992062	Safeskin Sterile Purple Nitrile Examination Gloves Summary page 1 …-Free Exam Glove (K051347) to which equivalency is · Kimberly-Clark* PURPLE NITRILE* Powder-Free Exam Glove, Sterile claimed: (K992062) Description of the device: Light gray nitrile, chlorinated, powder-free, sterile, textured fingertip,…	Safeskin Corp.	1999	—

Also cleared against K051347: 2 other devices →

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K102032	Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove)…	Kimberly-Clark Corp.	2010	8

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 10, 2016	Class II	Z-0758-2017	Under Investigation by firm	Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K102032 (Kimberly-Clark Corp., 2010) has gone furthest, with 8 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/K081027 · printed Nov 3, 2026

Cite this page

510(k) Report. “K081027: Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K081027

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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