510(k) · Cleared
ClearedMedline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industires, Inc. · LZC Medical Glove, Specialty
Cleared on Sep 18, 2020 as substantially equivalent to K172525 (Central Medicare Sdn Bhd, 2017) after a 114-day review. Its family tree reaches back 5 generations to 2004. 8 later devices descend from it.
- Decided
- Sep 18, 2020
- Review
- 114 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042805 (2004). 6 ancestors in all. 8 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK042805 Powder Free Nitrile Patient Examination Gloves, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2004
- 4 generations backK081089 Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam…Kimberly-Clark Corp. · 2008
- 3 generations backK141982 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2015
- 2 generations backK163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy…Hebei Hongsen Plastics Technology Co, Ltd. · 2017
- 1 generation backK172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for…Central Medicare Sdn Bhd · 2017
- This deviceK201390 Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use…Medline Industires, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK222898 SafeSource Direct Blue Powder-Free Nitrile Exam GlovesSafesource Direct, LLC · 2022
- Descendant · cites it directly · 1 of its ownK211714 Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with…Hengchang (Dongying) Medical Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK250502 SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF…Safesource Direct, LLC · 2025
- Descendant · cites it directly · 0 of its ownK222733 Disposable Nitrile Examination Glove (Tested for use with…Inner Mongolia Boming Medical Supplies Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK222642 Disposable Nitrile Examination Glove (Tested for use with…Inner Mongolia Cureguard Medical Technology Co., Ltd. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K222898SafeSource Direct Blue Powder-Free Nitrile Exam GlovesSafesource Direct, LLC · 2022 · cites it directly1descendant
- K211714Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)Hengchang (Dongying) Medical Technology Co., Ltd. · 2021 · cites it directly1descendant
- K250502SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000…Safesource Direct, LLC · 2025 · 2 generations on0descendants
- K222733Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)Inner Mongolia Boming Medical Supplies Co., Ltd. · 2022 · cites it directly0descendants
- K222642Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)Inner Mongolia Cureguard Medical Technology Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042805 | Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile | Perusahaan Getah Asas Sdn. Bhd. | 2004 | — |
| −4 | K081089 | Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with… | Kimberly-Clark Corp. | 2008 | — |
| −3 | 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 | — |
| −1 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with… | Central Medicare Sdn Bhd | 2017 | — |
| 0 (this device) | K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with… | Medline Industires, Inc. | 2020 | — |
| +1 | K222898 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves | Safesource Direct, LLC | 2022 | — |
| +1 | K211714 | Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) | Hengchang (Dongying) Medical Technology Co., Ltd. | 2021 | — |
| +2 | K250502 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series… | Safesource Direct, LLC | 2025 | — |
| +1 | K222733 | Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) | Inner Mongolia Boming Medical Supplies Co., Ltd. | 2022 | — |
| +1 | K222642 | Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) | Inner Mongolia Cureguard Medical Technology Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2025 | 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 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 K243959 Powder Free Nitrile Examination Gloves…score 9.5 · 3 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 |
|---|---|---|---|
| * | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy…Summary page 4…Regulatory Class: I Regulation Number: 21 CFR 880.6250 Predicate Device Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs – K172525 Page 1 of 7 Medline Industries, Inc.… | 2017 |
What descends from it? (8)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222898 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves | 2022 | 1 |
| K211714 | Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) | 2021 | 1 |
| K222733 | Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) | 2022 | 0 |
| K222642 | Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) | 2022 | 0 |
| K212834 | Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) | 2021 | 0 |
| K211608 | Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) | 2021 | 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?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K222898 (Safesource Direct, LLC, 2022) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K172525.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LZC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZC
85in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZC
10in 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?
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Carmustine (BCNU) 3.3 mg/ml 25.3 Minutes Cisplatin 1.0 mg/ml ≥ 240 Minutes Cyclophosphamide…
Read the full statement (173 words)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 25.3 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 0.5 mg/ml ≥ 240 Minutes
Methotrexate 25 mg/ml ≥ 240 Minutes
Mitomycin C 0.5 mg/ml ≥ 240 Minutes
Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes
Thio-Tepa 10.0 mg/ml 43.7 Minutes
Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 25.3 Minutes
Thio-Tepa 10.0 mg/ml 43.7 Minutes
Caution: Testing showed an average breakthrough time of 43.7 minutes with Thio-Tepa
WARNING: Do not use with Carmustine
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201390: Medline Powder-Free Light Blue Nitrile Exam 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/K201390
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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