510(k) · Cleared

Cleared

Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim

K081089510(k) TraditionalCleared Jul 14, 200889-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. · LZC Medical Glove, Specialty

Cleared on Jul 14, 2008 as substantially equivalent to K051347 (Kimberly-Clark Corp., 2005) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 2004. 86 later devices descend from it.

Decided: Jul 14, 2008
Review: 89 days
Class: Class I
Product code: LZC
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K042805 (2004). 2 ancestors in all. 86 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
This deviceK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
Descendant · cites it directly · 67 of its ownK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
Descendant · 2 generations on · 41 of its ownK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
Descendant · 3 generations on · 39 of its ownK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
Descendant · 4 generations on · 17 of its ownK173942 Blue Non Sterile powder free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2018
Descendant · 5 generations on · 13 of its ownK182600 Powder Free Nitrile Examination Glove, Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2018

Showing 5 of 86 descendants. See all descendants

Descendants cleared per year

2010high 16 (2022) · low 0 (2011)2026

Most influential descendants

Showing 5 of 86 · See all

K141982Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for…Wrp Asia Pacific Sdn. Bhd. · 2015 · cites it directly67descendants
K163146POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy DrugsHebei Hongsen Plastics Technology Co, Ltd. · 2017 · 2 generations on41descendants
K172525Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy…Central Medicare Sdn Bhd · 2017 · 3 generations on39descendants
K173942Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy…Central Medicare Sdn Bhd · 2018 · 4 generations on17descendants
K182600Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)Better Care Plastic Technology Co., Ltd. · 2018 · 5 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K042805	Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile	Perusahaan Getah Asas Sdn. Bhd.	2004	—
0 (this device)	K081089	Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with…	Kimberly-Clark Corp.	2008	—
+1	K141982	Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile…	Wrp Asia Pacific Sdn. Bhd.	2015	—
+2	K163146	POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs	Hebei Hongsen Plastics Technology Co, Ltd.	2017	—
+3	K172525	Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with…	Central Medicare Sdn Bhd	2017	—
+4	K173942	Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with…	Central Medicare Sdn Bhd	2018	—
+5	K182600	Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs…	Better Care Plastic Technology Co., Ltd.	2018	—

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	2	0
2012	1	0
2015	1	0
2016	5	0
2017	8	0
2018	8	0
2019	7	0
2020	5	0
2021	11	0
2022	16	0
2023	8	0
2024	6	0
2025	7	0
2026	1	0

FIG. 1 — Lineage of K081089, 2004–2026Source: 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 LZC? 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 LZC device

#1 K201390 Medline Powder-Free Light Blue Nitrile Exam…score 19.2 · 5 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 …n Name: Glove, Patient Examination, Specialty - 80 LZC Legally marketed device · Kimberly-Clark* STERLING* Nitrile Powder-Free Exam Glove - K051347 to which equivalency is · Perusahaan Getah Asas Sdn. Bhd. Powdered Free Patient Examination claimed:…	Kimberly-Clark Corp.	2005	—
*	K042805	Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile Summary page 1 …Gloves, Blue Colored Non-Sterile (Low Dermatitus Potential and Chemotherapy Drug Protection Labeling Claims) - K042805 Description of the device: Light gray nitrile, chlorinated, powder-free, textured fingertip, ambidextrous…	Perusahaan Getah Asas Sdn. Bhd.	2004	—

Also cleared against K051347: 2 other devices →

What descends from it? (86)

See all 86

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

Number	Device	Applicant	Decided	Descendants
K141982	Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for…	Wrp Asia Pacific Sdn. Bhd.	2015	67
K101596	Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and…	Kimberly-Clark	2010	11
K102032	Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove)…	Kimberly-Clark Corp.	2010	8
K183132	Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy…	O&M Halyard, Inc.	2019	1
K162186	Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Sterling/Grey] with…	Brightway Holdings Sdn. Bhd.	2017	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?

None of the 2 ancestors has a recall.
Of its descendants, K141982 (Wrp Asia Pacific Sdn. Bhd., 2015) has gone furthest, with 67 descendants of its own.
2 other devices also cite its predicate K051347.

How does its category compare?

All LZC devices

LZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · LZC

1in 2025

2007high 7 (2019) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZC

85in 2022

2007high 258 (2016) · low 68 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZC

1in 2021

2007high 4 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZC

10in 2025

2007high 16 (2024) · low 0 (2007)2025

MAUDE reports naming product code LZC, 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	1	—	0	0
2008	3	166	1	0
2009	5	253	0	1
2010	5	68	0	0
2011	0	—	4	1
2012	4	149	0	1
2013	0	—	0	1
2014	0	—	0	3
2015	1	—	0	0
2016	3	258	0	5
2017	6	121	0	7
2018	6	105	0	6
2019	7	200	0	8
2020	3	167	0	1
2021	3	94	1	2
2022	7	85	0	2
2023	0	—	0	1
2024	0	—	0	16
2025	1	—	0	10
2026	1	—	1	—

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/K081089 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081089: Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081089

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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