510(k) · Cleared
ClearedPowder Free Latex Patient Examination Glove, with Protein Content Labeling Claim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Top Calibre Sdn Bhd · LYY Latex Patient Examination Glove
Cleared on Jan 18, 2012 as substantially equivalent to K092492 (Wear Safe (Malaysia) Sdn. Bhd., 2009) after a 133-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.
- Decided
- Jan 18, 2012
- Review
- 133 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092492 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK092492 Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile…Wear Safe (Malaysia) Sdn. Bhd. · 2009
- This deviceK112612 Powder Free Latex Patient Examination Glove, with Protein Content…Top Calibre Sdn Bhd · 2012
- Descendant · cites it directly · 0 of its ownK153744 A1 Glove Powder Free Latex Patient Examination Gloves with Protein…A1 Glove Sdn Bhd · 2016
Most influential descendants
Showing 1 of 1 · See all- K153744A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling…A1 Glove Sdn Bhd · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092492 | Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein… | Wear Safe (Malaysia) Sdn. Bhd. | 2009 | — |
| 0 (this device) | K112612 | Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim | Top Calibre Sdn Bhd | 2012 | — |
| +1 | K153744 | A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content… | A1 Glove Sdn Bhd | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K092492 | Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling…Summary page 1…gloves, Latex - 80LYY, meets all of the requirements of ASTM D3578-05 (2010) Standard Specification for Rubber Examination Glove. Predicate Device: K092492, Powder Free Polymer Coated Latex Examination Glove, Non-Sterile, With Protein Labeling Claim of 50 Micrograms per din 2 O… | 2009 |
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 |
|---|---|---|---|
| K153744 | A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling… | 2016 | 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?
- Its one ancestor has no recall.
- Of its descendants, K153744 (A1 Glove Sdn Bhd, 2016) has gone furthest, with 0 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. 2012, 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 patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112612: Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112612
Report an extraction error
Are you the manufacturer?
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