510(k) · Cleared
ClearedPowdered Latex Exam Gloves with Protein Labeling (200UG/G or Less)
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 Aug 26, 2002 as substantially equivalent to K001327 (Premier Pathway Sdn. Bhd., 2000) and 1 other predicate after a 26-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Aug 26, 2002
- Review
- 26 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000390 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK000390 Vital Shield Gold Powdered Latex Examination Gloves with Protein…Sgmp Co., Ltd. · 2000
- This deviceK022530 Powdered Latex Exam Gloves with Protein Labeling (200UG/G or Less)Hycare Intl. Co., Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000390 | Vital Shield Gold Powdered Latex Examination Gloves with Protein Content… | Sgmp Co., Ltd. | 2000 | — |
| 0 (this device) | K022530 | Powdered Latex Exam Gloves with Protein Labeling (200UG/G or Less) | Hycare Intl. Co., Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K001327 | Powdered Latex Exam Gloves, Protein Labeling (150 Microgram or Less)Summary page 1…currently marketed by U.S. companies. It is Substantially Equivalent to the devices manufactured by Premier Pathway K001327, and SGMP Company Ltd. K000390. 5 1Ok) Summary page 2. Test Results (Means and/or Successful Results:… | 2000 |
| * | K000390 | Vital Shield Gold Powdered Latex Examination Gloves with Protein Content Labeling Claim…Summary page 1…anies. It is Substantially Equivalent to the devices manufactured by Premier Pathway K001327, and SGMP Company Ltd. K000390. 5 1Ok) Summary page 2. Test Results (Means and/or Successful Results: This device has met or ex… | 2000 |
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?
- None of the 2 ancestors has a recall.
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/K022530 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022530: Powdered Latex Exam Gloves with Protein Labeling (200UG/G or Less).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022530
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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