510(k) · Cleared
ClearedMedline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (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 Jan 10, 2020 as substantially equivalent to K180696 (Medline Industries, Inc., 2018) after a 137-day review. Its family tree reaches back 3 generations to 2016. 6 later devices descend from it.
- Decided
- Jan 10, 2020
- Review
- 137 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K160562 (2016). 6 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK160562 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP…Hartalega Snd. Bhd. · 2016
- 2 generations backK162982 Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal…Medline Industries, Inc. · 2017
- 1 generation backK180696 Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves…Medline Industries, Inc. · 2018
- This deviceK192315 Medline Green Ambidextrous Power-Free Nitrile Examination Gloves…Medline Industries, Inc. · 2020
- Descendant · cites it directly · 5 of its ownK211220 Nitrile Patient Examination Gloves Blue Tested For Use With…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2021
- Descendant · 2 generations on · 3 of its ownK213040 Nitrile Patient Examination Gloves Blue Tested For Use With…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK261793 Powder-free Nitrile Examination Gloves Tested for Use With…Maxter Healthcare, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK221747 Nitrile Patient Examination Gloves Tested For Use With Chemotherapy…Fitone Latex Products Co., Ltd. Guangdong · 2022
- Descendant · 3 generations on · 0 of its ownK223235 Nitrile Examination Gloves Powder Free (Tested for use with…Pt. Sintong Unigolden Glove · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K211220Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2021 · cites it directly5descendants
- K213040Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022 · 2 generations on3descendants
- K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and…Maxter Healthcare, Inc. · 2026 · 3 generations on0descendants
- K221747Nitrile Patient Examination Gloves Tested For Use With Chemotherapy DrugsFitone Latex Products Co., Ltd. Guangdong · 2022 · 2 generations on0descendants
- K223235Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)Pt. Sintong Unigolden Glove · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K160562 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for… | Hartalega Snd. Bhd. | 2016 | — |
| −2 | K162982 | Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP… | Medline Industries, Inc. | 2017 | — |
| −1 | K180696 | Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with… | Medline Industries, Inc. | 2018 | — |
| 0 (this device) | K192315 | Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with… | Medline Industries, Inc. | 2020 | — |
| +1 | K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy… | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021 | — |
| +2 | K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy… | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022 | — |
| +3 | K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs… | Maxter Healthcare, Inc. | 2026 | — |
| +2 | K221747 | Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs | Fitone Latex Products Co., Ltd. Guangdong | 2022 | — |
| +3 | K223235 | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) | Pt. Sintong Unigolden Glove | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K180696 | Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal…Summary page 5…21 CFR 880.6250 Predicate Device Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) – K180696 Page 1 of 8 Medline… | 2018 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile… | 2021 | 5 |
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 4 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K211220 (Guangdong Kingfa Sci. & Tech.Co., Ltd., 2021) has gone furthest, with 5 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. 2020, 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. Blenoxane (Bleomycin) 15.0 mg/ml >240 minutes Bortezomib 1.0 mg/ml >240 minutes Busulfan 6.0 mg/ml…
Read the full statement (248 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.
Blenoxane (Bleomycin) 15.0 mg/ml >240 minutes
Bortezomib 1.0 mg/ml >240 minutes
Busulfan 6.0 mg/ml >240 minutes
Carboplatin 10.0 mg./ml >240 minutes
Carmustine (BCNU) 3.3 mg/ml 13.2 minutes
Cetuximab (Eributux) 2.0 mg/ml >240 minutes
Cisplatin 1.0 mg/ml >240 minutes
Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes
Dacarbazine (DTIC)10.0 mg/ml >240 minutes
Docetaxel 10.0 mg/ml >240 minutes
Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes
Epirubicin (Ellence) 2.0 mg/ml >240 minutes
Etoposide (Toposar) 20.0 mg/ml >240 minutes
Fludarabine 25.0 mg/ml >240 minutes
Fluorouracil 50.0 mg/ml >240 minutes
Gemcitabine (Gemzar) 38.0 mg/ml >240 minutes
Idarubicin 1.0 mg/ml >240 minutes
Ifosfamide 50.0 mg/ml >240 minutes
Irinotecan 50.0 mg/ml >240 minutes
Mechlorethamine HCI 1.0 mg/ml >240 minutes
Melphalan 5.0 mg/ml >240 minutes
Methotrexate 25.0 mg/ml >240 minutes
Mitomycin C 0.5 mg/ml >240 minutes
Mitoxantrone 2.0 mg/ml >240 minutes
Oxaliplatin 5.0 mg/ml >240 minutes
Paclitaxel (Taxol) 6.0 mg/ml >240 minutes
Paraplatin 10.0 mg/ml >240 minutes
Pemetrexed 25.0 mg/ml >240 minutes
Raltitrexed 0.5 mg/ml >240 minutes
Rituximab 10.0 mg/ml >240 minutes
Thiotepa 10.0 mg/ml 44 minutes
Trisonex (Arsenic Trioxide) 1.0 mg/ml >240 minutes
Vidaza (Azacitidine) 25.0 mg/ml >240 minutes
Vinblastine 1.0 mg/ml >240 minutes
Vincristine Sulfate 1.0 mg/ml >240 minutes
Vinorelbine 10.0 mg/ml >240 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192315: Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (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/K192315
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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