510(k) · Cleared
ClearedPowder Free Natural Rubber Latex Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Worldmed Manufacturing Sdn. Bhd. · LYY Latex Patient Examination Glove
Cleared on Sep 6, 2013 as substantially equivalent to K110250 (Total Gloves Sdn Bhd, 2011) and 1 other predicate after a 438-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Sep 6, 2013
- Review
- 438 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K981767 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK981767 Qtexx Powderfree Latex Examination GlovesLatexx Partners Bhd. · 1998
- 1 generation backK110250 MPXX Powder Free Natural Rubber Examination GlovesTotal Gloves Sdn Bhd · 2011
- This deviceK121844 Powder Free Natural Rubber Latex Examination GlovesWorldmed Manufacturing Sdn. Bhd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981767 | Qtexx Powderfree Latex Examination Gloves | Latexx Partners Bhd. | 1998 | — |
| −1 | K110250 | MPXX Powder Free Natural Rubber Examination Gloves | Total Gloves Sdn Bhd | 2011 | — |
| 0 (this device) | K121844 | Powder Free Natural Rubber Latex Examination Gloves | Worldmed Manufacturing Sdn. Bhd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K110250 | MPXX Powder Free Natural Rubber Examination GlovesSummary page 1…ncy is claimed: Primary Predicate: MPXXT Powder Free Natural Rubber Latex Examination Gloves Company : Total Glove Company Sdn Bhd. 510O(K) :K1 102 50 Additional Predicate: Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile Company:… | 2011 |
| * | K101799 | Powder Free Latex Examination Gloves Blue (Colored), Non-Sterile, with Protein Labeling…Summary page 1…Additional Predicate: Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile Company: Wear Safe (Malaysia) Sdn. Bhd. 510(K): K101799 4.0 Description of the Device: The Powder Free Natural Rubber Latex Examination Gloves meets all the requirements of… | 2010 |
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 15 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K110250.
How does its category compare?
All LYY devicesLYY Latex Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Powder Free Natural Rubber Latex Examination Gloves Is a single use
disposable device Intended for medical purposes that Is worn on the hands of
healthcare and similar personnel to prevent contamination between the
healthcare personnel and the patient;
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121844 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121844: Powder Free Natural Rubber Latex Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121844
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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