510(k) · Cleared
ClearedPowder Free Medical Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · LYZ Vinyl Patient Examination Glove
Cleared on Dec 9, 1994 after a 105-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Dec 9, 1994
- Review
- 105 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK944182 Powder Free Medical GloveBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- Descendant · cites it directly · 1 of its ownK991615 Polyurethane Powder Free Dental Examination Glove, Polyurethane…Maxxim Medical · 1999
- Descendant · 2 generations on · 0 of its ownK022095 Duraclean with Lycra Powder Free Polyurethane Medical Examination…Wilshire Technologies · 2002
- Descendant · cites it directly · 0 of its ownK992865 Sensicare XP Vinyl Powder Free Medical Examination GloveMaxxim Medical · 1999
- Descendant · cites it directly · 0 of its ownK992122 Tru-Touch PF Vinyl Powder Free Examination GloveMaxxim Medical · 1999
Most influential descendants
Showing 4 of 4 · See all- K991615Polyurethane Powder Free Dental Examination Glove, Polyurethane Powder Free Medical…Maxxim Medical · 1999 · cites it directly1descendant
- K022095Duraclean with Lycra Powder Free Polyurethane Medical Examination GloveWilshire Technologies · 2002 · 2 generations on0descendants
- K992865Sensicare XP Vinyl Powder Free Medical Examination GloveMaxxim Medical · 1999 · cites it directly0descendants
- K992122Tru-Touch PF Vinyl Powder Free Examination GloveMaxxim Medical · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944182 | Powder Free Medical Glove | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | — |
| +1 | K991615 | Polyurethane Powder Free Dental Examination Glove, Polyurethane Powder Free… | Maxxim Medical | 1999 | — |
| +2 | K022095 | Duraclean with Lycra Powder Free Polyurethane Medical Examination Glove | Wilshire Technologies | 2002 | — |
| +1 | K992865 | Sensicare XP Vinyl Powder Free Medical Examination Glove | Maxxim Medical | 1999 | — |
| +1 | K992122 | Tru-Touch PF Vinyl Powder Free Examination Glove | Maxxim Medical | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LYZ? 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 LYZ device
- #1 K260860 Powder Free Synthetic Vinyl Exam Gloves (Blue…score 11.4 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K991615 (Maxxim Medical, 1999) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYZ
100in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYZ
2in 2025
MAUDE reports naming product code LYZ, 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 | 36 | 47 | 0 | 4 |
| 2008 | 18 | 90 | 0 | 0 |
| 2009 | 49 | 71 | 1 | 0 |
| 2010 | 72 | 66 | 0 | 2 |
| 2011 | 33 | 86 | 3 | 5 |
| 2012 | 25 | 84 | 1 | 5 |
| 2013 | 8 | 193 | 0 | 2 |
| 2014 | 40 | 226 | 0 | 6 |
| 2015 | 14 | 180 | 0 | 1 |
| 2016 | 11 | 145 | 1 | 11 |
| 2017 | 9 | 109 | 0 | 6 |
| 2018 | 10 | 80 | 0 | 0 |
| 2019 | 4 | 162 | 0 | 3 |
| 2020 | 4 | 85 | 0 | 1 |
| 2021 | 30 | 91 | 0 | 4 |
| 2022 | 10 | 100 | 0 | 1 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K944182 · printed Nov 5, 2026
Cite this page
510(k) Report. “K944182: Powder Free Medical Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944182
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026