510(k) · Cleared
ClearedDisposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Universal Medical Equipment Co., Ltd. · LAZ N-Acetylprocainamide Control Materials
Cleared on Sep 23, 2021 as substantially equivalent to K102593 (Zibo Yinghao Medical Products Co., Ltd., 2010) after a 114-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Sep 23, 2021
- Review
- 114 days
- Class
- Class I
- Product code
- LAZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K022765 (2002). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK022765 Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp. · 2002
- 3 generations backK071072 Shanghai China Star Corp. Powder Free Blue Nitrile Patient…Shanghai China Star Corp · 2007
- 2 generations backK090336 Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient…Sunmax Enterprise Shanghai Co., Ltd. · 2009
- 1 generation backK102593 Synthetic, Powder-Free Nitrile ExaminationZibo Yinghao Medical Products Co., Ltd. · 2010
- This deviceK211667 Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)Changzhou Universal Medical Equipment Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K022765 | Nitrile Powder-Free Examination Gloves | Allegiance Healthcare Corp. | 2002 | — |
| −3 | K071072 | Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination Glove | Shanghai China Star Corp | 2007 | — |
| −2 | K090336 | Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination… | Sunmax Enterprise Shanghai Co., Ltd. | 2009 | — |
| −1 | K102593 | Synthetic, Powder-Free Nitrile Examination | Zibo Yinghao Medical Products Co., Ltd. | 2010 | — |
| 0 (this device) | K211667 | Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) | Changzhou Universal Medical Equipment Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 LAZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K102593 | Synthetic, Powder-Free Nitrile ExaminationSummary page 4…vice Class: Class I Device Classification Number: 21 CFR 880.6250 Product Code: LZA 3. IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE Primary Predicate Device: K102593 Applicant: Zibo Yingbo Medical Products Co., Ltd Device Name: Synthetic Nitrile Patient Examination Gloves – Powder free, Blue Co… | 2010 |
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 19 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All LAZ devicesLAZ N-Acetylprocainamide Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LAZ
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LAZ
Too few LAZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LAZ
No recall names LAZ since 2007.
Adverse event reports per year · LAZ
No MAUDE report names LAZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Disposable Medical Synthetic Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
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/K211667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211667: Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211667
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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