510(k) · Cleared
ClearedPowdered Latex Exam Gloves, Pink, with/Without Strawberry Scent, Protein Labeling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sgmp Co., Ltd. · LYY Latex Patient Examination Glove
Cleared on Mar 29, 2000 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Mar 29, 2000
- Review
- 30 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK000671 Powdered Latex Exam Gloves, Pink, with/Without Strawberry Scent…Sgmp Co., Ltd. · 2000
- Descendant · cites it directly · 0 of its ownK072403 Non-Sterile, Powdered, Pink Latex Examination Gloves with Cherry…Sgmp Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK030993 Non-Sterile Powdered Green Colored Powdered Latex Patient…Sgmp Co., Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK030994 Non-Sterile Orange Colored Powdered Latex Patinet Examination Gloves…Sgmp Co., Ltd. · 2003
Most influential descendants
Showing 3 of 3 · See all- K072403Non-Sterile, Powdered, Pink Latex Examination Gloves with Cherry Flavour and Protein…Sgmp Co., Ltd. · 2008 · cites it directly0descendants
- K030993Non-Sterile Powdered Green Colored Powdered Latex Patient Examination Gloves with &…Sgmp Co., Ltd. · 2003 · cites it directly0descendants
- K030994Non-Sterile Orange Colored Powdered Latex Patinet Examination Gloves with & Without…Sgmp Co., Ltd. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000671 | Powdered Latex Exam Gloves, Pink, with/Without Strawberry Scent, Protein… | Sgmp Co., Ltd. | 2000 | — |
| +1 | K072403 | Non-Sterile, Powdered, Pink Latex Examination Gloves with Cherry Flavour and… | Sgmp Co., Ltd. | 2008 | — |
| +1 | K030993 | Non-Sterile Powdered Green Colored Powdered Latex Patient Examination Gloves… | Sgmp Co., Ltd. | 2003 | — |
| +1 | K030994 | Non-Sterile Orange Colored Powdered Latex Patinet Examination Gloves with &… | Sgmp Co., Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2008 | 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 LYY? 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 LYY device
- #1 K202377 Palm Care Latex Examination Powder Free Glovesscore 12.7 · 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072403 | Non-Sterile, Powdered, Pink Latex Examination Gloves with Cherry Flavour and Protein… | 2008 | 0 |
| K030993 | Non-Sterile Powdered Green Colored Powdered Latex Patient Examination Gloves with &… | 2003 | 0 |
| K030994 | Non-Sterile Orange Colored Powdered Latex Patinet Examination Gloves with & Without… | 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, K072403 (Sgmp Co., Ltd., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LYY devicesLYY Latex Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYY
150in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYY
1in 2025
MAUDE reports naming product code LYY, 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 | 12 | 75 | 0 | 11 |
| 2008 | 13 | 151 | 0 | 14 |
| 2009 | 7 | 76 | 0 | 11 |
| 2010 | 13 | 106 | 0 | 10 |
| 2011 | 11 | 127 | 1 | 4 |
| 2012 | 11 | 133 | 0 | 1 |
| 2013 | 6 | 131 | 0 | 2 |
| 2014 | 3 | 156 | 0 | 6 |
| 2015 | 3 | 251 | 0 | 5 |
| 2016 | 4 | 142 | 0 | 7 |
| 2017 | 4 | 230 | 0 | 7 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 7 |
| 2020 | 1 | — | 1 | 1 |
| 2021 | 8 | 188 | 0 | 1 |
| 2022 | 14 | 150 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K000671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000671: Powdered Latex Exam Gloves, Pink, with/Without Strawberry Scent, Protein Labeling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000671
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026