510(k) · Cleared
ClearedDisposable Powder Free 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
Crdlight Optoelectronic Technology Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Nov 11, 2021 as substantially equivalent to K200960 (Medline Industires, Inc., 2020) after a 92-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Nov 11, 2021
- Review
- 92 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 deviceK212532 Disposable Powder Free Nitrile Exam Gloves (Tested For Use With…Crdlight Optoelectronic Technology Co., Ltd. · 2021
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) | K212532 | Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy… | Crdlight Optoelectronic Technology Co., Ltd. | 2021 | — |
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 4…st For Use with Chemotherapy Drugs Classification: Class I Product code: LZA, LZC Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital C. Predicate device: K200960 Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) Medline Industries, Inc.… | 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 16 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. 2021, 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?
Disposable Powder Free Nitrile Exam Glove (Tested For Use With Chemotherapy Drugs) 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 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.…
Read the full statement (134 words)
Disposable Powder Free Nitrile Exam Glove (Tested For Use With Chemotherapy Drugs) 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 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug Concentration (mg/mL) Breakthrough time (minutes)
Carmustine (BCNU) 3.3 mg/mL 6.2min
Cisplatin 1.0 mg/mL >240min
Cyclophosphamide (Cytoxan) 20.0 mg/mL >240min
Dacarbazine (DTIC) 10.0 mg/mL >240min
Doxorubicin HCL (Adriamycin) 2.0 mg/mL >240min
Etoposide (Toposar) 20.0 mg/mL >240min
Fluorouracil (Adrucil) 50.0 mg/mL >240min
Paclitaxel (Taxol) 6.0 mg/mL >240min
ThioTEPA 10.0 mg/mL 8.4min
Methotrexate 25.0 mg/mL >240min
Vincristine sulfate 1.0 mg/mL >240min
Do not use with Carmustine or ThioTEPA.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212532: Disposable Powder Free 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/K212532
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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