510(k) · Cleared
ClearedNitrile disposable 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
Xingyu Medical Tech Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Jan 11, 2022 as substantially equivalent to K200960 (Medline Industires, Inc., 2020) after a 134-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Jan 11, 2022
- Review
- 134 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051378 (2005). No later device cites it as a predicate yet.
- Root · 2 generations backK051378 Powder-Free Blue Nitrile Examination Gloves (Tested for Use with…Medline · 2005
- 1 generation backK200960 Medline Powder Free Examination Gloves (Tested for use with…Medline Industires, Inc. · 2020
- This deviceK212735 Nitrile disposable examination gloves (Tested for use with…Xingyu Medical Tech Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051378 | Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy… | Medline | 2005 | — |
| −1 | K200960 | Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) | Medline Industires, Inc. | 2020 | — |
| 0 (this device) | K212735 | Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) | Xingyu Medical Tech Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K200960 | Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)Summary page 6…LOPMENT ZONE, WEIFANG CITY, SHANDONG PROVINCE, CHINA Chemotherapy Drugs) Company Name: Medline Industries, Inc. 510(K) Number: K200960 4. Device Description The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are non- sterile, singl… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 3 companies; a new generation was cleared every 14.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K200960.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are 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 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug —…
Read the full statement (239 words)
The Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) are 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 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug — Concentration — Breakthrough time
Carmustine (BCNU) — 3.3mg/ml (3,300ppm) — 47.9(68.2,47.9,69.3)
Cyclophosphamide (Cytoxan) — 20.Omg/ml (20,000ppm) — >240 min
Doxorubicin HCI — 2.0 mg/ml (2,000ppm) — >240 min
Etoposide — 20.0 mg/ml (20,000ppm) — >240 min
Fluorouracil — 50.0 mg/ml (50,000ppm) — >240 min
Paclitaxel — 6.0 mg/ml (6,000ppm) — >240 min
ThioTepa — 10.0 mg/ml (10,000ppm) — >240 min
Bleomycin Sulfate(Blenoxane) — 15mg/ml (15,000ppm) — >240 min
Carboplatin — 10 mg/ml (10,000ppm) — >240 min
Cisplatin — 1.0 mg/ml (1,00Oppm) — >240 min
Cytarabine — 100mg/ml(100,000ppm) — >240 min
Dacarbazine — 10.Omg/ml (10,000ppm) — >240 min
Idarubicin HCL — lmg/ml (1,00Oppm) — >240 min
Ifosfamide — 50mg/ml (50,00ppm) — >240 min
Mechlorethamine HCL — lmg/ml (1,000ppm) — >240 min
MESNA — 100mg/ml (100,000ppm) — >240 min
Methotrexate — 25mg/ml (25,000ppm) — >240 min
Mitomycin C — 0.5 mg/ml (500ppm) — >240 min
Mitoxantrone — 2mg/ml( 2,000ppm) — >240 min
Trisenox — 1 mg/ml(1,000ppm) — >240 min
Vincristine Sulfate — 1 mg/ml (1,000ppm) — >240 min
Do Not Use with Carmustine (BCNU).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212735: Nitrile disposable 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 4, 2026. https://510kreport.com/device/K212735
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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