510(k) · Cleared
ClearedQtexx Powderfree Latex Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Latexx Partners Bhd. · LYY Latex Patient Examination Glove
Cleared on Jun 11, 1998 after a 23-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jun 11, 1998
- Review
- 23 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK981767 Qtexx Powderfree Latex Examination GlovesLatexx Partners Bhd. · 1998
- Descendant · cites it directly · 3 of its ownK110250 MPXX Powder Free Natural Rubber Examination GlovesTotal Gloves Sdn Bhd · 2011
- Descendant · 2 generations on · 1 of its ownK210253 Best Glove-Latex Powder Free Examination GloveBestsafe Glove Co., Ltd. · 2021
- Descendant · 3 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 · 2 generations on · 0 of its ownK121844 Powder Free Natural Rubber Latex Examination GlovesWorldmed Manufacturing Sdn. Bhd. · 2013
Most influential descendants
Showing 4 of 4 · See all- K110250MPXX Powder Free Natural Rubber Examination GlovesTotal Gloves Sdn Bhd · 2011 · cites it directly3descendants
- K210253Best Glove-Latex Powder Free Examination GloveBestsafe Glove Co., Ltd. · 2021 · 2 generations on1descendant
- K221374Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)Hebei Titans Hongsen Medical Technology Co., Ltd. · 2022 · 3 generations on0descendants
- K121844Powder Free Natural Rubber Latex Examination GlovesWorldmed Manufacturing Sdn. Bhd. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981767 | Qtexx Powderfree Latex Examination Gloves | Latexx Partners Bhd. | 1998 | — |
| +1 | K110250 | MPXX Powder Free Natural Rubber Examination Gloves | Total Gloves Sdn Bhd | 2011 | — |
| +2 | K210253 | Best Glove-Latex Powder Free Examination Glove | Bestsafe Glove Co., Ltd. | 2021 | — |
| +3 | K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2022 | — |
| +2 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Class 1 patient examination glove 80LYY Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110250 | MPXX Powder Free Natural Rubber Examination Gloves | 2011 | 3 |
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?
- Of its descendants, K110250 (Total Gloves Sdn Bhd, 2011) has gone furthest, with 3 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?
OTEXX Powderfree Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
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/K981767 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981767: Qtexx Powderfree 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/K981767
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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