510(k) · Cleared
ClearedPowder Free Latex Examination Gloves, Natural or Blue Colour and with Protein Content Labeling Claim (50 UG or Less)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medipure Corporation (M) Sdn. Bhd. · LYY Latex Patient Examination Glove
Cleared on Aug 24, 2006 as substantially equivalent to K924356 (Medi Pure Corp., 1994) after an 80-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Aug 24, 2006
- Review
- 80 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924356 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK924356 Latex Patient Examination GlovesMedi Pure Corp. · 1994
- This deviceK061551 Powder Free Latex Examination Gloves, Natural or Blue Colour and…Medipure Corporation (M) Sdn. Bhd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924356 | Latex Patient Examination Gloves | Medi Pure Corp. | 1994 | — |
| 0 (this device) | K061551 | Powder Free Latex Examination Gloves, Natural or Blue Colour and with Protein… | Medipure Corporation (M) Sdn. Bhd. | 2006 | — |
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 |
|---|---|---|---|
| * | K924356 | Latex Patient Examination GlovesSummary page 1….0 Predicate Device Information: Unmodified Device Name Latex Patient Examination Gloves, Powder Free Cleared 510(k) K924356 Date Approved February 3, 1994… | 1994 |
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?
- Its one ancestor has no recall.
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?
The Powder Free Latex Examination Glove is a disposable device made of
natural rubber latex that may bear a trace amount of glove powder and is intended
to be worn on hands or finger(s) for medical purposes to provide a barrier against
potentially infectious materials and other contaminants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061551: Powder Free Latex Examination Gloves, Natural or Blue Colour and with Protein Content Labeling Claim (50 UG or Less).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061551
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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