510(k) · Cleared
ClearedNon-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate)
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 Jul 26, 2007 as substantially equivalent to K052016 (Sgmp Co., Ltd., 2005) after a 101-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Jul 26, 2007
- Review
- 101 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011377 (2001). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK011377 Non-Sterile Powder-Free Blue Latex Examination Gloves, with and…Sgmp Co., Ltd. · 2001
- 1 generation backK052016 Non-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow…Sgmp Co., Ltd. · 2005
- This deviceK071060 Non-Sterile, Latex Powder Free Patient Examination Gloves…Sgmp Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK093375 KS-Care Powder Free Polymer Coated Latex Examination Glove with…Koon Seng Sdn Bhd · 2009
Most influential descendants
Showing 1 of 1 · See all- K093375KS-Care Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling…Koon Seng Sdn Bhd · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011377 | Non-Sterile Powder-Free Blue Latex Examination Gloves, with and Without… | Sgmp Co., Ltd. | 2001 | — |
| −1 | K052016 | Non-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow Latex… | Sgmp Co., Ltd. | 2005 | — |
| 0 (this device) | K071060 | Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with… | Sgmp Co., Ltd. | 2007 | — |
| +1 | 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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K052016 | Non-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow Latex Examination…Summary page 1…No: 775-342-2613 E-mail: Tuckerjan~aol. corn Equivalent Predicate Device: POWDER FREE (MULTICOLORED) LATEX EXAM GLOVES which was granted a 510(k) # K052016 This sumnnary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. Devi… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093375 | KS-Care Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling… | 2009 | 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?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 4.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K093375 (Koon Seng Sdn Bhd, 2009) 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. 2007, this device’s year, is highlighted.
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?
This Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate, with Protein Labeling claims (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/K071060 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071060: Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071060
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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