510(k) · Cleared
ClearedMedline Powder Free Examination 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. · LZA Polymer Patient Examination Glove
Cleared on Jul 13, 2020 as substantially equivalent to K051378 (Medline, 2005) after a 94-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it.
- Decided
- Jul 13, 2020
- Review
- 94 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051378 (2005). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK051378 Powder-Free Blue Nitrile Examination Gloves (Tested for Use with…Medline · 2005
- This deviceK200960 Medline Powder Free Examination Gloves (Tested for use with…Medline Industires, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK212735 Nitrile disposable examination gloves (Tested for use with…Xingyu Medical Tech Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK212532 Disposable Powder Free Nitrile Exam Gloves (Tested For Use With…Crdlight Optoelectronic Technology Co., Ltd. · 2021
Most influential descendants
Showing 2 of 2 · See all- K212735Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)Xingyu Medical Tech Co., Ltd. · 2022 · cites it directly0descendants
- K212532Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)Crdlight Optoelectronic Technology Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051378 | Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy… | Medline | 2005 | — |
| 0 (this device) | K200960 | Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) | Medline Industires, Inc. | 2020 | — |
| +1 | K212735 | Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) | Xingyu Medical Tech Co., Ltd. | 2022 | — |
| +1 | K212532 | Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy… | Crdlight Optoelectronic Technology Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K051378 | Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)Summary page 4…egulatory Class: Class I Regulation Number: 21 CFR 880.6250 Predicate Device Medline Powder Free Blue Nitrile Examination Glove (Tested for use with Chemotherapy Drugs) K051378 Device Description The Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy drugs) are non… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K212735 (Xingyu Medical Tech Co., Ltd., 2022) has gone furthest, with 0 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. Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Concentration Breakthrough time Carmustine (BCNU)…
Read the full statement (164 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.
Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05
(Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug Concentration Breakthrough time
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 12.4 minutes
Cisplatin 1.0 mg/ml (1,000 ppm) >240 minutes
Cyclophosphamide (Cytoxan) 20.0 mg/ml (20,000 ppm) >240 minutes
Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) >240 minutes
Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) >240 minutes
Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) >240 minutes
Fluorouracil 50.0 mg/ ml (50,000 ppm) >240 minutes
Methotrexate 25 mg/ml (25,000 ppm) >240 minutes
Mitomycin C 0.5 mg/ml (500 ppm) >240 minutes
Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) >240 minutes
ThioTepa 10.0 mg/ml (10,000 ppm) 27.4 minutes
Vincristine Sulfate (Oncovin) 1.0 mg/ml (1,000 ppm) >240 minutes
Do Not Use with Carmustine or Thiotepa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200960: Medline 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/K200960
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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