510(k) · Cleared
ClearedKS-Care Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50UG or Less)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koon Seng Sdn Bhd · LYY Latex Patient Examination Glove
Cleared on Dec 2, 2009 as substantially equivalent to K071060 (Sgmp Co., Ltd., 2007) and 1 other predicate after a 34-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Dec 2, 2009
- Review
- 34 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K011377 (2001). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK011377 Non-Sterile Powder-Free Blue Latex Examination Gloves, with and…Sgmp Co., Ltd. · 2001
- 2 generations backK052016 Non-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow…Sgmp Co., Ltd. · 2005
- 1 generation backK071060 Non-Sterile, Latex Powder Free Patient Examination Gloves…Sgmp Co., Ltd. · 2007
- This deviceK093375 KS-Care Powder Free Polymer Coated Latex Examination Glove with…Koon Seng Sdn Bhd · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011377 | Non-Sterile Powder-Free Blue Latex Examination Gloves, with and Without… | Sgmp Co., Ltd. | 2001 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
| 2008 | 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 |
|---|---|---|---|
| * | K071060 | Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and…Summary page 2…labeling Claim Examination 510K # K(081488 (50 Micrograms Gloves or Less) 510K # K(071060 _______ ______ Product Code LYY LYY LYY _____ I… | 2007 |
| * | K081488 | Powder Free Latex Examination Gloves, Non-SterileSummary page 2…td. Powder-free Examination Protein Content Latex Gloves labeling Claim Examination 510K # K(081488 (50 Micrograms Gloves or Less) 510K # K(071060 _______… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All LYY devicesLYY Latex Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093375: KS-Care Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50UG or Less).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093375
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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