510(k) · Cleared
ClearedPowder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrp Asia Pacific Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Jan 17, 2020 as substantially equivalent to K133168 (Wrp Asia Pacific Sdn. Bhd., 2014) after a 116-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Jan 17, 2020
- Review
- 116 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022904 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK022904 Dermagrip-N/Multiple/WRP Asia Pacific SDN BHD Powder Free Nitrile…Wrp Asia Pacific Sdn. Bhd. · 2002
- 1 generation backK133168 Dermagrip Powder Free Blue Nitrile Patient Examination Gloves…Wrp Asia Pacific Sdn. Bhd. · 2014
- This deviceK192635 Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)Wrp Asia Pacific Sdn. Bhd. · 2020
- Descendant · cites it directly · 0 of its ownK220229 Powder Free Nitrile Examination Gloves, OrangeShanxi Hongjin Plastic Technology Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220229Powder Free Nitrile Examination Gloves, OrangeShanxi Hongjin Plastic Technology Co., Ltd. · 2022 · cites it directly0descendants
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 | K133168 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile | Wrp Asia Pacific Sdn. Bhd. | 2014 | — |
| 0 (this device) | K192635 | Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) | Wrp Asia Pacific Sdn. Bhd. | 2020 | — |
| +1 | K220229 | Powder Free Nitrile Examination Gloves, Orange | Shanxi Hongjin Plastic Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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 |
|---|---|---|---|
| * | K133168 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-SterileSummary page 4…ame: Patient Examination Gloves Device Classification: I Regulation Number: 21 CFR 880.6250 Product Code: LZA 3.0 Predicate Device: K133168 Dermagrip Powder Free Blue Nitrile Examination Gloves WRP Asia Pacific Sdn Bhd 4.0 Description of The Device:… | 2014 |
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 |
|---|---|---|---|
| K220229 | Powder Free Nitrile Examination Gloves, Orange | 2022 | 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?
- The line of descent spans 18 years and passes through 1 company; a new generation was cleared every 11.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K220229 (Shanxi Hongjin Plastic Technology Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K133168.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 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/K192635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192635: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192635
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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