510(k) · Cleared
ClearedSBG Blue Nitrile Powder Free Medical Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Showa Best Glove, Inc. · LZA Polymer Patient Examination Glove
Cleared on Oct 10, 2018 as substantially equivalent to K141590 (Eco Medi Glove Sdn. Bhd., 2014) after a 231-day review. Its family tree reaches back 3 generations to 2010. 1 later device descends from it.
- Decided
- Oct 10, 2018
- Review
- 231 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K100603 (2010). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK100603 RS Safe Blue Nitrile Medical Examination Gloves (Powder Free)Riverstone Resources Sdn Bhd · 2010 · Recalled
- 2 generations backK112928 RS Safe White Nitrile Medical Examination Gloves Powder Free or…Riverstone Resources Sdn Bhd · 2012
- 1 generation backK141590 Emg Blue Nitrile Medical Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2014
- This deviceK180467 SBG Blue Nitrile Powder Free Medical Examination GloveShowa Best Glove, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK203622 Medical GlovesBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K203622Medical GlovesBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K100603 | RS Safe Blue Nitrile Medical Examination Gloves (Powder Free) | Riverstone Resources Sdn Bhd | 2010 | 24 |
| −2 | K112928 | RS Safe White Nitrile Medical Examination Gloves Powder Free or Other… | Riverstone Resources Sdn Bhd | 2012 | — |
| −1 | K141590 | Emg Blue Nitrile Medical Examination Glove Powder Free | Eco Medi Glove Sdn. Bhd. | 2014 | — |
| 0 (this device) | K180467 | SBG Blue Nitrile Powder Free Medical Examination Glove | Showa Best Glove, Inc. | 2018 | — |
| +1 | K203622 | Medical Gloves | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141590 | Emg Blue Nitrile Medical Examination Glove Powder FreeSummary page 5…t Code: LZA 5. PREDICATE DEVICE Trade Name: EMG Blue Nitrile Medical Examination Glove Powder Free Common Name: Patient Examination Glove 510(k) Number: K141590 Manufacturer: ECO MEDI GLOVE SDN. BHD 6. INDICATIONS FOR USE A powder free patient examination gloves is a disposable… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203622 | Medical Gloves | 2021 | 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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K203622 (Beijing Biosis Healing Biolog Ical Technology Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K141590.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180467 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180467: SBG Blue Nitrile Powder Free Medical Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180467
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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