510(k) · Cleared
ClearedChlorinated, Polymer-Coated Powder-Free Latex Examination Glove with Protein Labeling Claim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kossan Latex Industries (M)Sdn Bhd · LYY Latex Patient Examination Glove
Cleared on Dec 22, 2006 after an 84-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Dec 22, 2006
- Review
- 84 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK062965 Chlorinated, Polymer-Coated Powder-Free Latex Examination Glove with…Kossan Latex Industries (M)Sdn Bhd · 2006
- Descendant · cites it directly · 1 of its ownK072145 Medical Glove SeriesZhanjiang Jiali Glove Products Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK150612 Annuy Latex Patient Examination Glove (powdered and powder-free)…Anhui Anyu Latex Products Co., Ltd. · 2015
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 |
|---|---|---|---|---|---|
| 0 (this device) | K062965 | Chlorinated, Polymer-Coated Powder-Free Latex Examination Glove with Protein… | Kossan Latex Industries (M)Sdn Bhd | 2006 | — |
| +1 | K072145 | Medical Glove Series | Zhanjiang Jiali Glove Products Co., Ltd. | 2008 | — |
| +2 | K150612 | Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy… | Anhui Anyu Latex Products Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2015 | 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K072145 | Medical Glove Series | 2008 | 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?
- Of its descendants, K072145 (Zhanjiang Jiali Glove Products Co., Ltd., 2008) 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?
A patient examination glove 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/K062965 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062965: Chlorinated, Polymer-Coated Powder-Free Latex Examination Glove with Protein Labeling Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062965
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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