510(k) · Cleared
ClearedHycare Latex Examination Glove, Powder Free
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hycare Intl. Co., Ltd. · LYY Latex Patient Examination Glove
Cleared on Jul 30, 2002 as substantially equivalent to K000391 (Sgmp Co., Ltd., 2000) and 1 other predicate after a 204-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jul 30, 2002
- Review
- 204 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000391 (2000). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000391 Vital Shield Gold Powder Free Latex Examination Gloves with Protein…Sgmp Co., Ltd. · 2000
- This deviceK020042 Hycare Latex Examination Glove, Powder FreeHycare Intl. Co., Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK211209 Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex…Hycare International Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K211209Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination GlovesHycare International Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000391 | Vital Shield Gold Powder Free Latex Examination Gloves with Protein Content… | Sgmp Co., Ltd. | 2000 | — |
| 0 (this device) | K020042 | Hycare Latex Examination Glove, Powder Free | Hycare Intl. Co., Ltd. | 2002 | — |
| +1 | K211209 | Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves | Hycare International Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K000391 | Vital Shield Gold Powder Free Latex Examination Gloves with Protein Content Labeling… | 2000 |
| * | K014134 | Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G) Cleared while this submission was under review Summary page 2…Primary Skin Irritation Conclusion: This device is substantially equivalent to the devices approved as KO00391 and K014134. DEPARTMENT OF HEALTH &HUNLAN SERVICES Public Health Service… | 2002 |
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 |
|---|---|---|---|
| K211209 | Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves | 2021 | 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 2 ancestors has a recall.
- Of its descendants, K211209 (Hycare International Co., Ltd., 2021) 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.
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/K020042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020042: Hycare Latex Examination Glove, Powder Free.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020042
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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