510(k) · Cleared
ClearedNon-Sterile Powder Free Purple Latex Examination Glove with and Without Grape Scent and with Protein Labeling (50 Microg
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 Jun 7, 2001 after a 34-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
- Jun 7, 2001
- Review
- 34 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK011370 Non-Sterile Powder Free Purple Latex Examination Glove with and…Sgmp Co., Ltd. · 2001
- Descendant · cites it directly · 1 of its ownK032293 Non-Sterile, Powder Free Green Latex Examination Gloves with or…Sgmp Co., Ltd. · 2003
- Descendant · 2 generations on · 0 of its ownK052666 Non-Sterile Powder Free Natural/Green Lano-E Latex Exam Gloves, with…Ascend Eagle, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK032294 Non-Sterile, Powder Free Orange Latex Examination Gloves W/ or…Sgmp Co., Ltd. · 2003
Most influential descendants
Showing 3 of 3 · See all- K032293Non-Sterile, Powder Free Green Latex Examination Gloves with or Without Sour Apple or…Sgmp Co., Ltd. · 2003 · cites it directly1descendant
- K052666Non-Sterile Powder Free Natural/Green Lano-E Latex Exam Gloves, with or Wihout…Ascend Eagle, Inc. · 2006 · 2 generations on0descendants
- K032294Non-Sterile, Powder Free Orange Latex Examination Gloves W/ or Without Orange/Vanilla…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) | K011370 | Non-Sterile Powder Free Purple Latex Examination Glove with and Without Grape… | Sgmp Co., Ltd. | 2001 | — |
| +1 | K032293 | Non-Sterile, Powder Free Green Latex Examination Gloves with or Without Sour… | Sgmp Co., Ltd. | 2003 | — |
| +2 | K052666 | Non-Sterile Powder Free Natural/Green Lano-E Latex Exam Gloves, with or Wihout… | Ascend Eagle, Inc. | 2006 | — |
| +1 | K032294 | Non-Sterile, Powder Free Orange Latex Examination Gloves W/ or Without… | Sgmp Co., Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2006 | 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)
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, K032293 (Sgmp Co., Ltd., 2003) has gone furthest, with 1 descendant 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/K011370 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011370: Non-Sterile Powder Free Purple Latex Examination Glove with and Without Grape Scent and with Protein Labeling (50 Microg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011370
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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