510(k) · Cleared
ClearedPowder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Deramatitis Potential and Chemotherapy Drug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perusahaan Getah Asas Sdn. Bhd. · LZC Medical Glove, Specialty
Cleared on Nov 29, 2010 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Nov 29, 2010
- Review
- 63 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK102790 Powder Free Nitrile Patient Examination Glove, Blue Colored…Perusahaan Getah Asas Sdn. Bhd. · 2010
- Descendant · cites it directly · 1 of its ownK151824 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2016
- Descendant · cites it directly · 1 of its ownK120066 Powder Free Nitrile Patient Examination Glove, Blue, White and Green…Kossan Latex Industries (M)Sdn Bhd · 2012
- Descendant · 2 generations on · 0 of its ownK183441 Powder-free Nitrile Patient Examination Glove, Green Colored…Semperit Investments Asia Pte, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK123749 Powder Free Nitrile Patient Examination Gloves, Green, Non-SterileKossan Latex Industries (M)Sdn Bhd · 2013
Most influential descendants
Showing 4 of 4 · See all- K151824Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis…Kossan International Sdn Bhd · 2016 · cites it directly1descendant
- K120066Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored.…Kossan Latex Industries (M)Sdn Bhd · 2012 · cites it directly1descendant
- K183441Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low…Semperit Investments Asia Pte, Ltd. · 2019 · 2 generations on0descendants
- K123749Powder Free Nitrile Patient Examination Gloves, Green, Non-SterileKossan Latex Industries (M)Sdn Bhd · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102790 | Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low… | Perusahaan Getah Asas Sdn. Bhd. | 2010 | — |
| +1 | K151824 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low… | Kossan International Sdn Bhd | 2016 | — |
| +1 | K120066 | Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored.… | Kossan Latex Industries (M)Sdn Bhd | 2012 | — |
| +2 | K183441 | Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low… | Semperit Investments Asia Pte, Ltd. | 2019 | — |
| +2 | K123749 | Powder Free Nitrile Patient Examination Gloves, Green, Non-Sterile | Kossan Latex Industries (M)Sdn Bhd | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZC? 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 LZC device
- #1 K201390 Medline Powder-Free Light Blue Nitrile Exam…score 19.2 · 5 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 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, K151824 (Kossan International Sdn Bhd, 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LZC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZC
85in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZC
10in 2025
MAUDE reports naming product code LZC, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 166 | 1 | 0 |
| 2009 | 5 | 253 | 0 | 1 |
| 2010 | 5 | 68 | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 4 | 149 | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 258 | 0 | 5 |
| 2017 | 6 | 121 | 0 | 7 |
| 2018 | 6 | 105 | 0 | 6 |
| 2019 | 7 | 200 | 0 | 8 |
| 2020 | 3 | 167 | 0 | 1 |
| 2021 | 3 | 94 | 1 | 2 |
| 2022 | 7 | 85 | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K102790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102790: Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Deramatitis Potential and Chemotherapy Drug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102790
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026