510(k) · Cleared
ClearedNitrile Powder Free Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jda Intl., Inc. · LZA Polymer Patient Examination Glove
Cleared on Nov 5, 1999 after a 38-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 67 later devices descend from it.
- Decided
- Nov 5, 1999
- Review
- 38 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
67 later devices descend from it, 7 citing it directly.
- This deviceK993247 Nitrile Powder Free Patient Examination GlovesJda Intl., Inc. · 1999
- Descendant · cites it directly · 34 of its ownK120970 Nitrile Powder Free Patient Examination Gloves, Colored (Blue)Tangshan Zhonghong Pulin Plastic Co.,Ltd · 2012
- Descendant · cites it directly · 26 of its ownK082598 Powder Free Blue Patient Nitrile Examination GloveTangshan Zhonghong Pulin Group Co., Ltd. · 2009
- Descendant · 2 generations on · 16 of its ownK121992 Powder-Free Nitrile Patient Examination Gloves, Blue ColorXinwei (Shandong) Plastic and Rubber Products Co., · 2012
- Descendant · 2 generations on · 15 of its ownK181106 Powder Free Nitrile Patient Examination Gloves, Blue ColorJiangsu Dongxin Medical Technology Co., Ltd. · 2019
- Descendant · 3 generations on · 15 of its ownK131440 Powder Free Nitrile Patient Examination Gloves, BlueHebei Hongsen Plastics Technology Co, Ltd. · 2013
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K120970Nitrile Powder Free Patient Examination Gloves, Colored (Blue)Tangshan Zhonghong Pulin Plastic Co.,Ltd · 2012 · cites it directly34descendants
- K082598Powder Free Blue Patient Nitrile Examination GloveTangshan Zhonghong Pulin Group Co., Ltd. · 2009 · cites it directly26descendants
- K121992Powder-Free Nitrile Patient Examination Gloves, Blue ColorXinwei (Shandong) Plastic and Rubber Products Co., · 2012 · 2 generations on16descendants
- K181106Powder Free Nitrile Patient Examination Gloves, Blue ColorJiangsu Dongxin Medical Technology Co., Ltd. · 2019 · 2 generations on15descendants
- K131440Powder Free Nitrile Patient Examination Gloves, BlueHebei Hongsen Plastics Technology Co, Ltd. · 2013 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993247 | Nitrile Powder Free Patient Examination Gloves | Jda Intl., Inc. | 1999 | — |
| +1 | K120970 | Nitrile Powder Free Patient Examination Gloves, Colored (Blue) | Tangshan Zhonghong Pulin Plastic Co.,Ltd | 2012 | — |
| +1 | K082598 | Powder Free Blue Patient Nitrile Examination Glove | Tangshan Zhonghong Pulin Group Co., Ltd. | 2009 | — |
| +2 | K121992 | Powder-Free Nitrile Patient Examination Gloves, Blue Color | Xinwei (Shandong) Plastic and Rubber Products Co., | 2012 | — |
| +2 | K181106 | Powder Free Nitrile Patient Examination Gloves, Blue Color | Jiangsu Dongxin Medical Technology Co., Ltd. | 2019 | — |
| +3 | K131440 | Powder Free Nitrile Patient Examination Gloves, Blue | Hebei Hongsen Plastics Technology Co, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 6 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 24 | 0 |
| 2022 | 12 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (67)
See all 677 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120970 | Nitrile Powder Free Patient Examination Gloves, Colored (Blue) | 2012 | 34 |
| K082598 | Powder Free Blue Patient Nitrile Examination Glove | 2009 | 26 |
| K110155 | Nitrile Powder Free Patient Examination Gloves | 2011 | 0 |
| K110146 | Nitrile Powder Free Patient Examination Gloves | 2011 | 0 |
| K110185 | Nitrile Powder Free Patient Examination Gloves | 2011 | 0 |
| K070404 | Nitrile Powder Free Patient Examination Gloves | 2007 | 0 |
| K030529 | Legend (Brand) Nitrile Powder-Free Patient Examination Glove | 2003 | 0 |
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?
- Of its descendants, K120970 (Tangshan Zhonghong Pulin Plastic Co.,Ltd, 2012) has gone furthest, with 34 descendants of its own.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 medical gloves are worn on the hands of healthcare and similar personnel to prevent
contamination between healthcare personnel and patient.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993247: Nitrile Powder Free Patient 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/K993247
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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