510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves, Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hong Xin Rubber Products Co., Ltd. · LZA Polymer Patient Examination Glove
Cleared on May 15, 2007 after a 48-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 4 later devices descend from it.
- Decided
- May 15, 2007
- Review
- 48 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
4 later devices descend from it, 4 citing it directly.
- This deviceK070861 Powder Free Nitrile Examination Gloves, BlueHong Xin Rubber Products Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK122408 Powder Free Nitrile Examination Gloves (Black, White, Green)Hongye Plastic Products Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK103770 Same/Various Distributors/ WE May Private LabelSyntex Healthcare Products Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK101594 Powder Free Nitrile Patient Examination Gloves, BlueBetter Care Plastic Technology Cp., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK101595 Powder Free Nitrile Patient Examination Gloves, BlueBetter Care Plastic Technology Cp., Ltd. · 2010
Most influential descendants
Showing 4 of 4 · See all- K122408Powder Free Nitrile Examination Gloves (Black, White, Green)Hongye Plastic Products Co., Ltd. · 2013 · cites it directly0descendants
- K103770Same/Various Distributors/ WE May Private LabelSyntex Healthcare Products Co., Ltd. · 2011 · cites it directly0descendants
- K101594Powder Free Nitrile Patient Examination Gloves, BlueBetter Care Plastic Technology Cp., Ltd. · 2010 · cites it directly0descendants
- K101595Powder Free Nitrile Patient Examination Gloves, BlueBetter Care Plastic Technology Cp., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070861 | Powder Free Nitrile Examination Gloves, Blue | Hong Xin Rubber Products Co., Ltd. | 2007 | — |
| +1 | K122408 | Powder Free Nitrile Examination Gloves (Black, White, Green) | Hongye Plastic Products Co., Ltd. | 2013 | — |
| +1 | K103770 | Same/Various Distributors/ WE May Private Label | Syntex Healthcare Products Co., Ltd. | 2011 | — |
| +1 | K101594 | Powder Free Nitrile Patient Examination Gloves, Blue | Better Care Plastic Technology Cp., Ltd. | 2010 | — |
| +1 | K101595 | Powder Free Nitrile Patient Examination Gloves, Blue | Better Care Plastic Technology Cp., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K001128 | FDA’s K001128 is Nitrile Exam Gloves, Powder-Free, Color Blue Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K122408 (Hongye Plastic Products Co., Ltd., 2013) has gone furthest, with 0 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. 2007, 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?
A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070861 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070861: Powder Free Nitrile Examination Gloves, Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070861
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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