510(k) · Cleared
ClearedPowder Free Nitrile Examination Glove, Blue Colored, Black Colored and White Colored
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encompass Medical Supplies Inc Limited · LZA Polymer Patient Examination Glove
Cleared on May 2, 2012 as substantially equivalent to K103734 (Central Medicare Sdn Bhd, 2011) after a 100-day review. Its family tree reaches back 2 generations to 2010.
- Decided
- May 2, 2012
- Review
- 100 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K093696 (2010). No later device cites it as a predicate yet.
- Root · 2 generations backK093696 SR Glove, NU Glove, Highstress Model 801, Model 802, Model 803Central Medicare Sdn Bhd · 2010
- 1 generation backK103734 Powder Free Nitrile Examination Gloves White Colored Non-SterileCentral Medicare Sdn Bhd · 2011
- This deviceK120184 Powder Free Nitrile Examination Glove, Blue Colored, Black Colored…Encompass Medical Supplies Inc Limited · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K093696 | SR Glove, NU Glove, Highstress Model 801, Model 802, Model 803 | Central Medicare Sdn Bhd | 2010 | — |
| −1 | K103734 | Powder Free Nitrile Examination Gloves White Colored Non-Sterile | Central Medicare Sdn Bhd | 2011 | — |
| 0 (this device) | K120184 | Powder Free Nitrile Examination Glove, Blue Colored, Black Colored and White… | Encompass Medical Supplies Inc Limited | 2012 | — |
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 LZA? 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 LZA device
- #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 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 |
|---|---|---|---|
| * | K103734 | Powder Free Nitrile Examination Gloves White Colored Non-SterileSummary page 1…Class I Product Code: LZA 5.6 Predicate device: Powder Free Nitrile Examination Gloves, White Colored (K1 03734) 5.7 Identification of The Legally Marketed Device: The Powder Free Colored Nitrile Examination Glove Class I patient… | 2011 |
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?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K103734.
How does its category compare?
All LZA devicesLZA Polymer 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 · LZA
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZA
110in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZA
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZA
73in 2025
MAUDE reports naming product code LZA, 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 | 21 | 95 | 0 | 7 |
| 2008 | 18 | 97 | 0 | 2 |
| 2009 | 28 | 112 | 0 | 12 |
| 2010 | 31 | 97 | 0 | 12 |
| 2011 | 26 | 122 | 0 | 9 |
| 2012 | 33 | 110 | 0 | 11 |
| 2013 | 20 | 130 | 0 | 10 |
| 2014 | 27 | 197 | 0 | 8 |
| 2015 | 20 | 112 | 1 | 12 |
| 2016 | 30 | 171 | 1 | 25 |
| 2017 | 44 | 124 | 0 | 4 |
| 2018 | 22 | 178 | 0 | 3 |
| 2019 | 25 | 212 | 0 | 21 |
| 2020 | 30 | 101 | 0 | 4 |
| 2021 | 139 | 111 | 0 | 20 |
| 2022 | 146 | 111 | 0 | 19 |
| 2023 | 62 | 92 | 0 | 24 |
| 2024 | 30 | 89 | 0 | 76 |
| 2025 | 24 | 110 | 0 | 73 |
| 2026 | 15 | 103 | 3 | — |
What is it indicated for?
The Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) is a disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120184 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120184: Powder Free Nitrile Examination Glove, Blue Colored, Black Colored and White Colored.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120184
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