510(k) · Cleared
ClearedMedical PVC Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangxi Hongda Medical Equipment Group, Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Jul 9, 2021 as substantially equivalent to K182043 (Hebei Titans Hongsen Medical Technology Co., Ltd., 2018) after a 112-day review. Its family tree reaches back 6 generations to 2009.
- Decided
- Jul 9, 2021
- Review
- 112 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K091431 (2009). No later device cites it as a predicate yet.
- Root · 6 generations backK091431 Powder-Free, Yellow Vinyl Patient Examination GlovesZibo Yusheng Plastic Products Co., Ltd. · 2009
- 5 generations backK142508 Powder Free Yellow Vinyl Patient Examination GlovesZibo Huaqi Trading Co., Ltd. · 2014
- 4 generations backK150224 Blue Vinyl Gloves Powder FreeZibo Sanying Trade Co., Ltd. · 2015
- 3 generations backK163168 Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue)…Hebei Hongtai Plastic Products Company Limited · 2017
- 2 generations backK180849 Vinyl Examination Glove (Clear, Non-Colored)Huifu Trading Co., Ltd. · 2018
- 1 generation backK182043 Single-use medical poly (vinyl chloride) examination glove (Clear…Hebei Titans Hongsen Medical Technology Co., Ltd. · 2018
- This deviceK210821 Medical PVC Examination GlovesJiangxi Hongda Medical Equipment Group, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K091431 | Powder-Free, Yellow Vinyl Patient Examination Gloves | Zibo Yusheng Plastic Products Co., Ltd. | 2009 | — |
| −5 | K142508 | Powder Free Yellow Vinyl Patient Examination Gloves | Zibo Huaqi Trading Co., Ltd. | 2014 | — |
| −4 | K150224 | Blue Vinyl Gloves Powder Free | Zibo Sanying Trade Co., Ltd. | 2015 | — |
| −3 | K163168 | Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl… | Hebei Hongtai Plastic Products Company Limited | 2017 | — |
| −2 | K180849 | Vinyl Examination Glove (Clear, Non-Colored) | Huifu Trading Co., Ltd. | 2018 | — |
| −1 | K182043 | Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2018 | — |
| 0 (this device) | K210821 | Medical PVC Examination Gloves | Jiangxi Hongda Medical Equipment Group, 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 LYZ? 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 LYZ device
- #1 K260860 Powder Free Synthetic Vinyl Exam Gloves (Blue…score 11.4 · 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 |
|---|---|---|---|
| * | K182043 | Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)Summary page 5…al purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner. 5. Predicate Device Identification 510(k) Number: K182043 Product Name: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) Manufacturer: HEBEI TITAN… | 2018 |
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 12 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K182043.
How does its category compare?
All LYZ devicesLYZ Vinyl 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 · LYZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYZ
100in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYZ
2in 2025
MAUDE reports naming product code LYZ, 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 | 36 | 47 | 0 | 4 |
| 2008 | 18 | 90 | 0 | 0 |
| 2009 | 49 | 71 | 1 | 0 |
| 2010 | 72 | 66 | 0 | 2 |
| 2011 | 33 | 86 | 3 | 5 |
| 2012 | 25 | 84 | 1 | 5 |
| 2013 | 8 | 193 | 0 | 2 |
| 2014 | 40 | 226 | 0 | 6 |
| 2015 | 14 | 180 | 0 | 1 |
| 2016 | 11 | 145 | 1 | 11 |
| 2017 | 9 | 109 | 0 | 6 |
| 2018 | 10 | 80 | 0 | 0 |
| 2019 | 4 | 162 | 0 | 3 |
| 2020 | 4 | 85 | 0 | 1 |
| 2021 | 30 | 91 | 0 | 4 |
| 2022 | 10 | 100 | 0 | 1 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Medical PVC Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands 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/K210821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210821: Medical PVC Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210821
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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