510(k) · Cleared
ClearedPowder Free Latex Patient Exam Glove with Protein Labeling Claim (50 Micrograms Per DM Squared or Less of Water Soluble
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Northstar Healthcare Holdings Limited · LYY Latex Patient Examination Glove
Cleared on Nov 9, 2011 as substantially equivalent to K932521 (Top Glove Sdn. Bhd., 1994) after a 34-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Nov 9, 2011
- Review
- 34 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932521 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK932521 Powderfree Latex Examination GlovesTop Glove Sdn. Bhd. · 1994
- This deviceK112988 Powder Free Latex Patient Exam Glove with Protein Labeling Claim (50…Northstar Healthcare Holdings Limited · 2011
- Descendant · cites it directly · 0 of its ownK123757 Powder Free Latex Patient Examination Gloves, with Protein Content…Assurguard Sdn. Bhd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K123757Powder Free Latex Patient Examination Gloves, with Protein Content Labeling Claim…Assurguard 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 | K932521 | Powderfree Latex Examination Gloves | Top Glove Sdn. Bhd. | 1994 | — |
| 0 (this device) | K112988 | Powder Free Latex Patient Exam Glove with Protein Labeling Claim (50… | Northstar Healthcare Holdings Limited | 2011 | — |
| +1 | K123757 | Powder Free Latex Patient Examination Gloves, with Protein Content Labeling… | Assurguard Sdn. Bhd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K932521 | Powderfree Latex Examination GlovesSummary page 1…duct Code: LYY PREDICATE DEVICE(S): Predicate Dvice Name Indication Clearance Company 510(k) 7-Date -1(932521 Pwder Free Latex The patient examination glove is a 73 1994 Top Glove… | 1994 |
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 |
|---|---|---|---|
| K123757 | Powder Free Latex Patient Examination Gloves, with Protein Content Labeling Claim… | 2013 | 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, K123757 (Assurguard Sdn. Bhd., 2013) 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. 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?
The 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/K112988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112988: Powder Free Latex Patient Exam Glove with Protein Labeling Claim (50 Micrograms Per DM Squared or Less of Water Soluble.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112988
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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