510(k) · Cleared
ClearedBest Glove-Latex Powder Free Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bestsafe Glove Co., Ltd. · LYY Latex Patient Examination Glove
Cleared on Nov 5, 2021 as substantially equivalent to K110250 (Total Gloves Sdn Bhd, 2011) after a 280-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Nov 5, 2021
- Review
- 280 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981767 (1998). 1 later device descends from it, 1 citing it directly.
- 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 deviceK210253 Best Glove-Latex Powder Free Examination GloveBestsafe Glove Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK221374 Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)Hebei Titans Hongsen Medical Technology Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221374Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)Hebei Titans Hongsen Medical Technology Co., Ltd. · 2022 · cites it directly0descendants
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) | K210253 | Best Glove-Latex Powder Free Examination Glove | Bestsafe Glove Co., Ltd. | 2021 | — |
| +1 | K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K110250 | MPXX Powder Free Natural Rubber Examination GlovesSummary page 4…MPXXTM Powder Free Natural Rubber Latex Examination Gloves Manufacturer: Total Glove Company Sdn. Bhd. 510(k): K110250 Device Class: I Product Code: LYY… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | 2022 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K221374 (Hebei Titans Hongsen Medical Technology Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 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. 2021, 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?
A powder-free 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/K210253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210253: Best Glove-Latex Powder Free Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210253
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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