510(k) · Cleared

Cleared

Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs

K110921510(k) TraditionalCleared Apr 15, 201114-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

Cardinal Health, Inc. · LZA Polymer Patient Examination Glove

Cleared on Apr 15, 2011 as substantially equivalent to K022765 (Allegiance Healthcare Corp., 2002) after a 14-day review. Its family tree reaches back 1 generation to 2002. 7 later devices descend from it.

Decided: Apr 15, 2011
Review: 14 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K022765 (2002). 7 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK022765 Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp. · 2002
This deviceK110921 Nitrile Powder-Free Examination Gloves Tested for Use with…Cardinal Health, Inc. · 2011
Descendant · cites it directly · 6 of its ownK141623 Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug…Eco Medi Glove Sdn. Bhd. · 2014
Descendant · 2 generations on · 3 of its ownK152542 Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis…Riverstone Resources Sdn Bhd · 2015
Descendant · 3 generations on · 1 of its ownK181066 Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis…Eco Medi Glove Sdn. Bhd. · 2018
Descendant · 4 generations on · 0 of its ownK233560 Powder Free Nitrile Examination Glove Blue with Low Dermatitis…Eco Medi Glove Sdn. Bhd. · 2024
Descendant · 3 generations on · 0 of its ownK193121 GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential…Eco Medi Glove Sdn. Bhd. · 2020

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2014high 2 (2016) · low 0 (2017)2026

Most influential descendants

Showing 5 of 7 · See all

K141623Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling ClaimEco Medi Glove Sdn. Bhd. · 2014 · cites it directly6descendants
K152542Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and…Riverstone Resources Sdn Bhd · 2015 · 2 generations on3descendants
K181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested…Eco Medi Glove Sdn. Bhd. · 2018 · 3 generations on1descendant
K233560Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested…Eco Medi Glove Sdn. Bhd. · 2024 · 4 generations on0descendants
K193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with…Eco Medi Glove Sdn. Bhd. · 2020 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K022765	Nitrile Powder-Free Examination Gloves	Allegiance Healthcare Corp.	2002	—
0 (this device)	K110921	Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs	Cardinal Health, Inc.	2011	—
+1	K141623	Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling Claim	Eco Medi Glove Sdn. Bhd.	2014	—
+2	K152542	Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential…	Riverstone Resources Sdn Bhd	2015	—
+3	K181066	Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and…	Eco Medi Glove Sdn. Bhd.	2018	—
+4	K233560	Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential…	Eco Medi Glove Sdn. Bhd.	2024	—
+3	K193121	GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and…	Eco Medi Glove Sdn. Bhd.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	1	0
2016	2	0
2018	1	0
2020	1	0
2024	1	0

FIG. 1 — Lineage of K110921, 2002–2024Source: 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? (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
*	K022765	Nitrile Powder-Free Examination Gloves Summary page 2 …(10 mg/ml) Predicate Devices: Nitrile Blue Powder-Free Examination Gloves with Tested for Use with Chemotherapy Drug Labeling Claim previously cleared under 5 10O(k) K022765 (product code LZA); Substantial Equivalence: The gloves are substantially equivalent to the predicate device identified in this…	Allegiance Healthcare Corp.	2002	—

Also cleared against K022765: 3 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K141623	Emg Blue Nitrile Medical Examination Glove with Chemotherapy Drug Labeling Claim	Eco Medi Glove Sdn. Bhd.	2014	6

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, K141623 (Eco Medi Glove Sdn. Bhd., 2014) has gone furthest, with 6 descendants of its own.
3 other devices also cite its predicate K022765.

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. 2011, 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?

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug and Concentration — Minimum Breakthrough Detection Time…

Read the full statement (156 words)

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Chemotherapy Drug and Concentration — Minimum Breakthrough Detection Time in Minutes, 0.01 jgg/cm2/minute

1. Carmustine (BCNU) (3.3 mg/mI) — 0.61

2. Cisplastm, (1.0mg/mi) — >240

3. Cyclophosphamide (20 mg/mI) — >240

4. -Doxorubicin HCI (2.0 mg/mI) — >240

5. Etoposide (Toposar) (20 mg/mI) — >240

6. 5-Fluorouracil (50 mg/mI) — >240

7. Methotrexate (25 mg/nil) .>240

8. Paclitaxel (Taxol) (6.0 mg/mI) — >240

9. 1Thiotepa (10 mg/mI) — 10.6

The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time of less than 30 minutes:

Carmustine (BCNU) (3.3 mg/mI)

Thiotepa (10 mg/mI)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110921 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110921: Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110921

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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