510(k) · Cleared
ClearedMedical Glove Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhanjiang Jiali Glove Products Co., Ltd. · LYY Latex Patient Examination Glove
Cleared on Feb 26, 2008 as substantially equivalent to K062965 (Kossan Latex Industries (M)Sdn Bhd, 2006) and 3 other predicates after a 208-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.
- Decided
- Feb 26, 2008
- Review
- 208 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K060858 (2006). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK060858 Latex Powdered Examination GloveHigh Momentum Sdn Bhd · 2006
- This deviceK072145 Medical Glove SeriesZhanjiang Jiali Glove Products Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK150612 Annuy Latex Patient Examination Glove (powdered and powder-free)…Anhui Anyu Latex Products Co., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150612Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient…Anhui Anyu Latex Products Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060858 | Latex Powdered Examination Glove | High Momentum Sdn Bhd | 2006 | — |
| 0 (this device) | K072145 | Medical Glove Series | Zhanjiang Jiali Glove Products Co., Ltd. | 2008 | — |
| +1 | K150612 | Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy… | Anhui Anyu Latex Products Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K062965 | Chlorinated, Polymer-Coated Powder-Free Latex Examination Glove with Protein Labeling…Summary page 2…ong~mid-link.net 3. Predicate Device 1). CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM K Number: K062965 Product Code: LYY Intended Use: A patient examination glove is a disposable device intended for medical purposes that is worn on… | 2006 |
| * | K060858 | Latex Powdered Examination GloveSummary page 2…patient and examiner. Manufactured by KOSSAN LATEX INDUSTRIES (M) SDN. BHD. 2530 Riva Road, suite 308 Annapolis, MD 21401 2). LATEX POWDERED EXAMINATION GLOVE K Number: K060858 Product Code: LYY Intended Use: A patient examination glove is a disposable device intended for medical purposes that is worn on… | 2006 |
| * | K063046 | Nitrile Powder Free Examination Gloves (Green)Summary page 2…nd or finger to prevent contamination between patient and examiner. Manufactured by HIGH MOMENTUM SDN BHD 3). NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) K Number: K063 046 Product Code: LZA Intended Use: The nitrile examination gloves is a disposable device intended for medical and dental purpose tha… | 2006 |
| * | K063522 | Powder Nitrile Examination Glove (White and Blue Color)Summary page 2…t is worn on the examiner's hand to prevent contamination between patient and examiner. Manufactured by Hartalega SDN BHD 4). POWDER NITRILE EXAMINATION GLOVE K Number: K063522 111-2 Appendix HIl. 5 10(k)… | 2007 |
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 |
|---|---|---|---|
| K150612 | Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient… | 2015 | 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?
- None of the 4 ancestors has a recall.
- Of its descendants, K150612 (Anhui Anyu Latex Products Co., Ltd., 2015) 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. 2008, 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 patient examination glove is disposable devices intended for medical purpose that is worn on the hand or finger(s) to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072145: Medical Glove Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072145
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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