510(k) · Cleared
ClearedSingle-use medical latex examination gloves (LG100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fitone Latex Products Co., Ltd. Guangdong · LYY Latex Patient Examination Glove
Cleared on Sep 24, 2022 as substantially equivalent to K214017 (Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd., 2022) after an 18-day review. Its family tree reaches back 4 generations to 2016.
- Decided
- Sep 24, 2022
- Review
- 18 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K152593 (2016). No later device cites it as a predicate yet.
- Root · 4 generations backK152593 Latex Examination Glove Powder FreeCareplus (M) Sdn Bhd · 2016
- 3 generations backK161833 Latex Examination Glove Powder FreeCareglove Global Sdn. Bhd. · 2017
- 2 generations backK173053 Powder Free Latex Examination GloveProfessional Latex Sdn Bhd · 2018
- 1 generation backK214017 Examination gloves-Type A (Latex gloves)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · 2022
- This deviceK222693 Single-use medical latex examination gloves (LG100)Fitone Latex Products Co., Ltd. Guangdong · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K152593 | Latex Examination Glove Powder Free | Careplus (M) Sdn Bhd | 2016 | — |
| −3 | K161833 | Latex Examination Glove Powder Free | Careglove Global Sdn. Bhd. | 2017 | — |
| −2 | K173053 | Powder Free Latex Examination Glove | Professional Latex Sdn Bhd | 2018 | — |
| −1 | K214017 | Examination gloves-Type A (Latex gloves) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | 2022 | — |
| 0 (this device) | K222693 | Single-use medical latex examination gloves (LG100) | Fitone Latex Products Co., Ltd. Guangdong | 2022 | — |
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 |
|---|---|---|---|
| * | K214017 | Examination gloves-Type A (Latex gloves)Summary page 4…80.6250 Regulatory Class: Class I Product code: LYY Review Panel: General Hospital III. Predicate Devices 510(k) Number: K214017 Trade name: Examination gloves-Type A (Latex gloves) Common name: Latex Patient Examination Glove… | 2022 |
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 6 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K214017.
How does its category compare?
All LYY devicesLYY Latex Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The Single-use medical latex examination gloves 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222693 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222693: Single-use medical latex examination gloves (LG100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222693
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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