510(k) · Cleared
ClearedPowder-Free Latex examination gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Kingfa Sci. & Tech.Co., Ltd. · LYY Latex Patient Examination Glove
Cleared on Nov 25, 2022 as substantially equivalent to K214017 (Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd., 2022) after an 87-day review. Its family tree reaches back 4 generations to 2016.
- Decided
- Nov 25, 2022
- Review
- 87 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 deviceK222612 Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd. · 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) | K222612 | Powder-Free Latex examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 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…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 Gloves… | 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 powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222612: Powder-Free Latex examination gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222612
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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