510(k) · Cleared
ClearedNon-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow Latex Examination Gloves with Protein Content 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 Sep 1, 2005 as substantially equivalent to K011377 (Sgmp Co., Ltd., 2001) and 1 other predicate after a 37-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Sep 1, 2005
- Review
- 37 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011377 (2001). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011377 Non-Sterile Powder-Free Blue Latex Examination Gloves, with and…Sgmp Co., Ltd. · 2001
- This deviceK052016 Non-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow…Sgmp Co., Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK071060 Non-Sterile, Latex Powder Free Patient Examination Gloves…Sgmp Co., Ltd. · 2007
- Descendant · 2 generations on · 0 of its ownK093375 KS-Care Powder Free Polymer Coated Latex Examination Glove with…Koon Seng Sdn Bhd · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011377 | Non-Sterile Powder-Free Blue Latex Examination Gloves, with and Without… | Sgmp Co., Ltd. | 2001 | — |
| 0 (this device) | K052016 | Non-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow Latex… | Sgmp Co., Ltd. | 2005 | — |
| +1 | K071060 | Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with… | Sgmp Co., Ltd. | 2007 | — |
| +2 | K093375 | KS-Care Powder Free Polymer Coated Latex Examination Glove with Protein… | Koon Seng Sdn Bhd | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 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 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? (2)
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 |
|---|---|---|---|
| * | K011377 | Non-Sterile Powder-Free Blue Latex Examination Gloves, with and Without Bubblegum… | 2001 |
| * | K011371 | Non-Sterile Powder Free Pink Latex Examination Glove and Non-Sterile Powder Free Pink…Summary page 1…lent Predicate Device: POWDER FREE BLUE LATEX EXAM GLOVES which was granted a 510(k) # KO1 1377 and POWDER-FREE PINK LATEX EXAM GLOVES which was also granted a 510 (k) # K01 1371 as shown in APPENDIX M This summary of safety and effectiveness information is being submitted in accordance with the requiremen… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071060 | Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and… | 2007 | 1 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K071060 (Sgmp Co., Ltd., 2007) 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 | — |
What is it indicated for?
The Non-Sterile, Latex, Powder-Free Patient Examination Gloves (Multicolored), with Protein Labeling Claim (50 Micrograms or less) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052016: Non-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow Latex Examination Gloves with Protein Content Labeling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052016
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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