510(k) · Cleared
ClearedExamination gloves-Type A (Latex gloves)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · LYY Latex Patient Examination Glove
Cleared on Jul 14, 2022 as substantially equivalent to K173053 (Professional Latex Sdn Bhd, 2018) after a 204-day review. Its family tree reaches back 3 generations to 2016. 2 later devices descend from it.
- Decided
- Jul 14, 2022
- Review
- 204 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K152593 (2016). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK152593 Latex Examination Glove Powder FreeCareplus (M) Sdn Bhd · 2016
- 2 generations backK161833 Latex Examination Glove Powder FreeCareglove Global Sdn. Bhd. · 2017
- 1 generation backK173053 Powder Free Latex Examination GloveProfessional Latex Sdn Bhd · 2018
- This deviceK214017 Examination gloves-Type A (Latex gloves)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK222612 Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK222693 Single-use medical latex examination gloves (LG100)Fitone Latex Products Co., Ltd. Guangdong · 2022
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 |
|---|---|---|---|---|---|
| −3 | K152593 | Latex Examination Glove Powder Free | Careplus (M) Sdn Bhd | 2016 | — |
| −2 | K161833 | Latex Examination Glove Powder Free | Careglove Global Sdn. Bhd. | 2017 | — |
| −1 | K173053 | Powder Free Latex Examination Glove | Professional Latex Sdn Bhd | 2018 | — |
| 0 (this device) | K214017 | Examination gloves-Type A (Latex gloves) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | 2022 | — |
| +1 | K222612 | Powder-Free Latex examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022 | — |
| +1 | K222693 | Single-use medical latex examination gloves (LG100) | Fitone Latex Products Co., Ltd. Guangdong | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 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? (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 |
|---|---|---|---|
| * | K173053 | Powder Free Latex Examination GloveSummary page 4…Latex patient examination glove Classification Name: Non- powdered patient examination glove Regulatory Class: I Product Code: LYY III. PREDICATE DEVICE 510(k) Number: K173053 Product Name: Powder Free Latex Examination Glove Manufacture: Professional Latex Sdn Bhd… | 2018 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K222612 (Guangdong Kingfa Sci. & Tech.Co., Ltd., 2022) 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. 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 Examination gloves-Type A (Latex 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 as stated in the FDA summary.
https://510kreport.com/device/K214017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214017: Examination gloves-Type A (Latex gloves).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214017
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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