510(k) · Cleared
ClearedNon-Sterile Powder Free Pink Latex Examination Glove and Non-Sterile Powder Free Pink Latex Examination Glove with Straw
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. 4 later devices descend from it.
- Decided
- Jun 7, 2001
- Review
- 34 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK011371 Non-Sterile Powder Free Pink Latex Examination Glove and Non-Sterile…Sgmp Co., Ltd. · 2001
- Descendant · cites it directly · 2 of its ownK052016 Non-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow…Sgmp Co., Ltd. · 2005
- Descendant · 2 generations on · 1 of its ownK071060 Non-Sterile, Latex Powder Free Patient Examination Gloves…Sgmp Co., Ltd. · 2007
- Descendant · 3 generations on · 0 of its ownK093375 KS-Care Powder Free Polymer Coated Latex Examination Glove with…Koon Seng Sdn Bhd · 2009
- Descendant · cites it directly · 0 of its ownK072406 Non-Sterile, Powder Free, Pink Latex Examination Gloves with Cherry…Sgmp Co., Ltd. · 2008
Most influential descendants
Showing 4 of 4 · See all- K052016Non-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow Latex Examination…Sgmp Co., Ltd. · 2005 · cites it directly2descendants
- K071060Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and…Sgmp Co., Ltd. · 2007 · 2 generations on1descendant
- K093375KS-Care Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling…Koon Seng Sdn Bhd · 2009 · 3 generations on0descendants
- K072406Non-Sterile, Powder Free, Pink Latex Examination Gloves with Cherry Flavour and Protein…Sgmp Co., Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011371 | Non-Sterile Powder Free Pink Latex Examination Glove and Non-Sterile Powder… | Sgmp Co., Ltd. | 2001 | — |
| +1 | K052016 | Non-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow Latex… | Sgmp Co., Ltd. | 2005 | — |
| +2 | K071060 | Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with… | Sgmp Co., Ltd. | 2007 | — |
| +3 | K093375 | KS-Care Powder Free Polymer Coated Latex Examination Glove with Protein… | Koon Seng Sdn Bhd | 2009 | — |
| +1 | K072406 | Non-Sterile, Powder Free, Pink Latex Examination Gloves with Cherry Flavour… | Sgmp Co., Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (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, K052016 (Sgmp Co., Ltd., 2005) has gone furthest, with 2 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/K011371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011371: Non-Sterile Powder Free Pink Latex Examination Glove and Non-Sterile Powder Free Pink Latex Examination Glove with Straw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011371
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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