510(k) · Cleared
ClearedPowder Free Nitrile Examination Glove (Blue) (This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smart Glove Corp. Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Apr 18, 2005 after an 89-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Apr 18, 2005
- Review
- 89 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK050122 Powder Free Nitrile Examination Glove (Blue) (This Product Does Not…Smart Glove Corp. Sdn Bhd · 2005
- Descendant · cites it directly · 3 of its ownK152542 Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis…Riverstone Resources Sdn Bhd · 2015
- Descendant · 2 generations on · 1 of its ownK181066 Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis…Eco Medi Glove Sdn. Bhd. · 2018
- Descendant · 3 generations on · 0 of its ownK233560 Powder Free Nitrile Examination Glove Blue with Low Dermatitis…Eco Medi Glove Sdn. Bhd. · 2024
- Descendant · 2 generations on · 0 of its ownK193121 GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential…Eco Medi Glove Sdn. Bhd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K152542Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and…Riverstone Resources Sdn Bhd · 2015 · cites it directly3descendants
- K181066Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested…Eco Medi Glove Sdn. Bhd. · 2018 · 2 generations on1descendant
- K233560Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested…Eco Medi Glove Sdn. Bhd. · 2024 · 3 generations on0descendants
- K193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with…Eco Medi Glove Sdn. Bhd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050122 | Powder Free Nitrile Examination Glove (Blue) (This Product Does Not Contain… | Smart Glove Corp. Sdn Bhd | 2005 | — |
| +1 | K152542 | Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential… | Riverstone Resources Sdn Bhd | 2015 | — |
| +2 | K181066 | Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and… | Eco Medi Glove Sdn. Bhd. | 2018 | — |
| +3 | K233560 | Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential… | Eco Medi Glove Sdn. Bhd. | 2024 | — |
| +2 | K193121 | GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and… | Eco Medi Glove Sdn. Bhd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152542 | Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and… | 2015 | 3 |
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, K152542 (Riverstone Resources Sdn Bhd, 2015) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 glove is disposable and intended for medical
purpose that is worn on the examiner's hand to
prevent contamination between patient and examiner.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050122 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050122: Powder Free Nitrile Examination Glove (Blue) (This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050122
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