510(k) · Cleared
ClearedMPXX Powder Free Natural Rubber Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Total Gloves Sdn Bhd · LYY Latex Patient Examination Glove
Cleared on Oct 14, 2011 as substantially equivalent to K981767 (Latexx Partners Bhd., 1998) after a 259-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it.
- Decided
- Oct 14, 2011
- Review
- 259 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981767 (1998). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK981767 Qtexx Powderfree Latex Examination GlovesLatexx Partners Bhd. · 1998
- This deviceK110250 MPXX Powder Free Natural Rubber Examination GlovesTotal Gloves Sdn Bhd · 2011
- Descendant · cites it directly · 1 of its ownK210253 Best Glove-Latex Powder Free Examination GloveBestsafe Glove Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK221374 Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)Hebei Titans Hongsen Medical Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK121844 Powder Free Natural Rubber Latex Examination GlovesWorldmed Manufacturing Sdn. Bhd. · 2013
Most influential descendants
Showing 3 of 3 · See all- K210253Best Glove-Latex Powder Free Examination GloveBestsafe Glove Co., Ltd. · 2021 · cites it directly1descendant
- K221374Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)Hebei Titans Hongsen Medical Technology Co., Ltd. · 2022 · 2 generations on0descendants
- K121844Powder Free Natural Rubber Latex Examination GlovesWorldmed Manufacturing Sdn. Bhd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981767 | Qtexx Powderfree Latex Examination Gloves | Latexx Partners Bhd. | 1998 | — |
| 0 (this device) | K110250 | MPXX Powder Free Natural Rubber Examination Gloves | Total Gloves Sdn Bhd | 2011 | — |
| +1 | K210253 | Best Glove-Latex Powder Free Examination Glove | Bestsafe Glove Co., Ltd. | 2021 | — |
| +2 | K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2022 | — |
| +1 | K121844 | Powder Free Natural Rubber Latex Examination Gloves | Worldmed Manufacturing Sdn. Bhd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K981767 | Qtexx Powderfree Latex Examination GlovesSummary page 1…d in this 510 K Notification is substantially equivalent to K981767, Otexx Powder-Free Latex Examination Gloves with 50 Micrograms or Less of… | 1998 |
What descends from it? (3)
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?
- Its one ancestor has no recall.
- Of its descendants, K210253 (Bestsafe Glove Co., Ltd., 2021) has gone furthest, with 1 descendant 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. 2011, 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?
MPXXTM Powder Free Natural Rubber Latex Examination Gloves are intended for single use for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between healthcare personnel and the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110250: MPXX Powder Free Natural Rubber 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/K110250
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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