510(k) · Cleared
ClearedPowder Free Blude Nitrile Patient Examination Glove, Non-Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Health Products, Lot 60 & 61 · LZA Polymer Patient Examination Glove
Cleared on Jun 30, 2014 as substantially equivalent to K110979 (Advanced Medical Products Sdn Bhd, 2011) after a 336-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Jun 30, 2014
- Review
- 336 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022904 (2002). No later device cites it as a predicate yet.
- Root · 2 generations backK022904 Dermagrip-N/Multiple/WRP Asia Pacific SDN BHD Powder Free Nitrile…Wrp Asia Pacific Sdn. Bhd. · 2002
- 1 generation backK110979 Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves…Advanced Medical Products Sdn Bhd · 2011 · Recalled
- This deviceK132354 Powder Free Blude Nitrile Patient Examination Glove, Non-SterileAdvanced Health Products, Lot 60 & 61 · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022904 | Dermagrip-N/Multiple/WRP Asia Pacific SDN BHD Powder Free Nitrile Examination… | Wrp Asia Pacific Sdn. Bhd. | 2002 | — |
| −1 | K110979 | Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves… | Advanced Medical Products Sdn Bhd | 2011 | 1 |
| 0 (this device) | K132354 | Powder Free Blude Nitrile Patient Examination Glove, Non-Sterile | Advanced Health Products, Lot 60 & 61 | 2014 | — |
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 |
|---|---|---|---|
| * | K110979 | Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile,Tested…Summary page 1…Devices that equivalency is claimed: Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile (and various brandnames) 510(k) :K110979 MDL :D133849 Regulatory Class I Product Code : LZA 4.0 Description of The Device: Dermagrip… | 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 12 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
A patient examination glove is a disposable device intended for medical purposes that is worn on the examinees hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132354: Powder Free Blude Nitrile Patient Examination Glove, Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132354
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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