510(k) · Cleared
ClearedBiodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Kingfa Sci. & Tech.Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on Apr 27, 2023 as substantially equivalent to K162312 (Shen Wei USA, Inc., 2017) after a 295-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Apr 27, 2023
- Review
- 295 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K993876 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK993876 Powder-Free Nitrile Examination Gloves with Aloe VeraShen Wei (Usa), Inc. · 2000
- 1 generation backK162312 Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green…Shen Wei USA, Inc. · 2017
- This deviceK221983 Biodegradable Powder Free Nitrile Examination Glove, Blue Color…Guangdong Kingfa Sci. & Tech.Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993876 | Powder-Free Nitrile Examination Gloves with Aloe Vera | Shen Wei (Usa), Inc. | 2000 | — |
| −1 | K162312 | Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color | Shen Wei USA, Inc. | 2017 | — |
| 0 (this device) | K221983 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable… | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K162312 | Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green ColorSummary page 4…21 CFR 880.6250 Regulatory Class: Class I Product code: LZA Review Panel General Hospital III. Predicate Device 510(k) Number: K162312 Trade name: Biodegradable Powder Free Nitrile Exam Gloves With Aloe Vera, Green Color Common name: Pati… | 2017 |
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 23 years and passes through 3 companies; a new generation was cleared every 17.5 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 biodegradable nitrile examination glove is intended to be worn on the hands of examiner’s to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221983 · printed Nov 3, 2026
Cite this page
510(k) Report. “K221983: Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K221983
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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