510(k) · Cleared
ClearedGlovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avecena Gloves Sdn Bhd · LYY Latex Patient Examination Glove
Cleared on Apr 24, 2022 as substantially equivalent to K192329 (Jr Engineering & Medical Technologies (M) Sdn. Bhd., 2019) and 1 other predicate after a 143-day review. Its family tree reaches back 4 generations to 2010.
- Decided
- Apr 24, 2022
- Review
- 143 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K100603 (2010). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK100603 RS Safe Blue Nitrile Medical Examination Gloves (Powder Free)Riverstone Resources Sdn Bhd · 2010 · Recalled
- 3 generations backK112924 RS Safe Black Nitrile Medical Examination Gloves Powder or Other…Riverstone Resources Sdn Bhd · 2012
- 2 generations backK141579 Emg Black Nitrile Medical Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2014
- 1 generation backK200326 Powder Free Nitrile Examination Glove (Aqua Green)Riverstone Resources Sdn Bhd · 2020
- This deviceK213775 Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile GlovesAvecena Gloves Sdn Bhd · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K100603 | RS Safe Blue Nitrile Medical Examination Gloves (Powder Free) | Riverstone Resources Sdn Bhd | 2010 | 24 |
| −3 | K112924 | RS Safe Black Nitrile Medical Examination Gloves Powder or Other Proprietary… | Riverstone Resources Sdn Bhd | 2012 | — |
| −2 | K141579 | Emg Black Nitrile Medical Examination Glove Powder Free | Eco Medi Glove Sdn. Bhd. | 2014 | — |
| −1 | K200326 | Powder Free Nitrile Examination Glove (Aqua Green) | Riverstone Resources Sdn Bhd | 2020 | — |
| 0 (this device) | K213775 | Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves | Avecena Gloves Sdn Bhd | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K192329 | Blue Latex Examination Powder Free GlovesSummary page 4…Manufacturer JR Engineering & Glovatex™ White K213775 K192329 Medical Technologies Latex Gloves (M) SDN.BHD. Glova… | 2019 |
| * | K200326 | Powder Free Nitrile Examination Glove (Aqua Green)Summary page 4…SDN.BHD. Glovanil™ Blue Nitrile Riverstone Resource K213775 K200326 Gloves Sdn Bhd. Device Description Glovatex™ White Lat… | 2020 |
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 12 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 5 other devices also cite its predicate K192329.
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 Glovatex™ White Latex Glove is a disposable device intended for Medical purpose that is worn on the examiner’s hands or finger to prevent contamination patient and examiner.
The Glovanil™ Blue Nitrile Glove is a disposable device intended for Medical purpose that is worn on the examiner’s hands or finger to prevent contamination 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/K213775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213775: Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213775
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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