510(k) · Cleared
ClearedMedline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · LZA Polymer Patient Examination Glove
Cleared on Apr 30, 2018 as substantially equivalent to K162982 (Medline Industries, Inc., 2017) after a 45-day review. Its family tree reaches back 2 generations to 2016. 7 later devices descend from it.
- Decided
- Apr 30, 2018
- Review
- 45 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K160562 (2016). 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK160562 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP…Hartalega Snd. Bhd. · 2016
- 1 generation backK162982 Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal…Medline Industries, Inc. · 2017
- This deviceK180696 Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves…Medline Industries, Inc. · 2018
- Descendant · cites it directly · 6 of its ownK192315 Medline Green Ambidextrous Power-Free Nitrile Examination Gloves…Medline Industries, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK211220 Nitrile Patient Examination Gloves Blue Tested For Use With…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2021
- Descendant · 3 generations on · 3 of its ownK213040 Nitrile Patient Examination Gloves Blue Tested For Use With…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK261793 Powder-free Nitrile Examination Gloves Tested for Use With…Maxter Healthcare, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK221747 Nitrile Patient Examination Gloves Tested For Use With Chemotherapy…Fitone Latex Products Co., Ltd. Guangdong · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K192315Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal…Medline Industries, Inc. · 2020 · cites it directly6descendants
- K211220Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2021 · 2 generations on5descendants
- K213040Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022 · 3 generations on3descendants
- K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and…Maxter Healthcare, Inc. · 2026 · 4 generations on0descendants
- K221747Nitrile Patient Examination Gloves Tested For Use With Chemotherapy DrugsFitone Latex Products Co., Ltd. Guangdong · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K160562 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for… | Hartalega Snd. Bhd. | 2016 | — |
| −1 | K162982 | Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP… | Medline Industries, Inc. | 2017 | — |
| 0 (this device) | K180696 | Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with… | Medline Industries, Inc. | 2018 | — |
| +1 | K192315 | Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with… | Medline Industries, Inc. | 2020 | — |
| +2 | K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy… | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021 | — |
| +3 | K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy… | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022 | — |
| +4 | K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs… | Maxter Healthcare, Inc. | 2026 | — |
| +3 | K221747 | Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs | Fitone Latex Products Co., Ltd. Guangdong | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2026 | 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? (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 | Decided |
|---|---|---|---|
| * | K162982 | Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use…Summary page 4…pital Regulation #: 21 CFR 880.6250 Predicate Device Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) - K162982 Page 1 of 8 Medline Industries, Inc.… | 2017 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192315 | Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal… | 2020 | 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?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K192315 (Medline Industries, Inc., 2020) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Carmustine (BCNU) 3.3 mg/ml 13.2 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan)…
Read the full statement (152 words)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to
prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice
for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 13.2 minutes
Cisplatin 1.0 mg/ml >240 minutes
Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes
Dacarbazine (DTIC)10.0 mg/ml >240 minutes
Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes
Etoposide (Toposar) 20.0 mg/ml >240 minutes
Fluorouracil 50.0 mg/ml >240 minutes
Methotrexate 25.0 mg/ml >240 minutes
Mitomycin C 0.5 mg/ml >240 minutes
Paclitaxel (Taxol) 6.0 mg/ml >240 minutes
Thiotepa 10.0 mg/ml 44.0 minutes
Vincristine Sulfate 1.0 mg/ml >240 minutes
Please note that the following drug has extremely low permeation times:
Carmustine (BCNU) (3.3 mg/ml) 13.2 minutes
Please note that the following drug has low permeation times:
Thiotepa (10.0 mg/ml) 44.0 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180696 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180696: Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180696
Report an extraction error
Are you the manufacturer?
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