510(k) · Cleared
ClearedMedline Nitrile Powder-Free Examination Glove 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 Feb 27, 2017 as substantially equivalent to K160562 (Hartalega Snd. Bhd., 2016) after a 124-day review. Its family tree reaches back 1 generation to 2016. 8 later devices descend from it.
- Decided
- Feb 27, 2017
- Review
- 124 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K160562 (2016). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK160562 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP…Hartalega Snd. Bhd. · 2016
- This deviceK162982 Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal…Medline Industries, Inc. · 2017
- Descendant · cites it directly · 7 of its ownK180696 Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves…Medline Industries, Inc. · 2018
- Descendant · 2 generations on · 6 of its ownK192315 Medline Green Ambidextrous Power-Free Nitrile Examination Gloves…Medline Industries, Inc. · 2020
- Descendant · 3 generations on · 5 of its ownK211220 Nitrile Patient Examination Gloves Blue Tested For Use With…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2021
- Descendant · 4 generations on · 3 of its ownK213040 Nitrile Patient Examination Gloves Blue Tested For Use With…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022
- Descendant · 5 generations on · 0 of its ownK261793 Powder-free Nitrile Examination Gloves Tested for Use With…Maxter Healthcare, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K180696Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal…Medline Industries, Inc. · 2018 · cites it directly7descendants
- K192315Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal…Medline Industries, Inc. · 2020 · 2 generations on6descendants
- K211220Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2021 · 3 generations on5descendants
- K213040Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2022 · 4 generations on3descendants
- K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and…Maxter Healthcare, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K160562 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for… | Hartalega Snd. Bhd. | 2016 | — |
| 0 (this device) | 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 | — |
| +2 | K192315 | Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with… | Medline Industries, Inc. | 2020 | — |
| +3 | K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy… | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021 | — |
| +4 | K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy… | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022 | — |
| +5 | K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs… | Maxter Healthcare, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K160562 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with…Summary page 5…General Hospital Regulation #: 21 CFR 880.6250 Predicate Device Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs K160562 Medline Industries, Inc. One Medline Place Mundelein, IL 60060… | 2016 |
| † | K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free… | 2016 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180696 | Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal… | 2018 | 7 |
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, K180696 (Medline Industries, Inc., 2018) has gone furthest, with 7 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. 2017, 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 mg/ml >240 minutes Bortezomib 1 mg/ml >240 minutes Busulfan 6 mg/ml >240…
Read the full statement (283 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 mg/ml >240 minutes
Bortezomib 1 mg/ml >240 minutes
Busulfan 6 mg/ml >240 minutes
Carboplatin 10.0 mg/ml >240 minutes
Carmustine (BCNU) 3.3 mg/ml 11.9 minutes
Cetuximab (Erbitux) 2 mg/ml >240 minutes
Cisplatin 1.0 mg.ml >240 minutes
Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes
Cytarabine 100 mg/ml >240 minutes
Dacarbazine (DTIC)10.0 mg/ml >240 minutes
Daunorubicin 5 mg/ml >240 minutes
Docetaxel 10.0 mg/ml >240 minutes
Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes
Ellence 2 mg/ml >240 minutes
Etoposide (Toposar) 20.0 mg/ml >240 minutes
Fludarabine 25 mg/ml >240 minutes
Fluorouracil 50.0 mg/ml >240 minutes
Gemcitabine (Gemzar) 38 mg/ml >240 minutes
Idarubicin 1 mg/ml >240 minutes
Ifosfamide 50.0 mg/ml >240 minutes
Irinotecan 20.0 mg/ml >240 minutes
Mechlorethamine HCI 1.0 mg/ml >240 minutes
Melphalan 5 mg/ml >240 minutes
Methotrexate 25 mg/ml >240 minutes
Methotrexate 50 mg/ml >240 minutes
Mitomycin C 0.5 mg/ml >240 minutes
Mitoxantrone 2.0 mg/ml >240 minutes
Oxaliplatin 5 mg/ml >240 minutes
Paclitaxel (Taxol) 6.0 mg/ml >240 minutes
Paraplatin 10 mg/ml >240 minutes
Pemetrexed Disodium 25 mg/ml >240 minutes
Raltitrexed 0.5 mg/ml >240 minutes
Rituximab 10 mg/ml >240 minutes
Thiotepa 10.0 mg/ml 18.6 minutes
Trisonex 0.1 mg/ml >240 minutes
Vidaza (5-Azacytidine) 25 mg/ml >240 minutes
Vinblastine 1 mg/ml >240 minutes
Vinorelbine 10 mg/ml >240 minutes
Vincristine Sulfate 1.0 mg/ml >240 minutes
Please note that the following drugs have extremely low permeation times:
Carmustine (BCNU) (3.3 mg/ml) 11.9 minutes
Thiotepa (10.0 mg/ml) 18.6 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162982: Medline Nitrile Powder-Free Examination Glove 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/K162982
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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