510(k) · Cleared
ClearedSterile Nitrile Powder Free Examination Glove (Vblu), Sterle Nitrile Powder Free Examination Glove (Ablu)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hartalega Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Nov 7, 2013 after a 129-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Nov 7, 2013
- Review
- 129 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK132006 Sterile Nitrile Powder Free Examination Glove (Vblu), Sterle Nitrile…Hartalega Sdn Bhd · 2013
- Descendant · cites it directly · 5 of its ownK171093 Sterile Nitrile Patient Examination Gloves, PowderfreeSanrea Healthcare Products Pvt, Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK180452 White Nitrile Examination Glove, Sterile with Chemotherapy Drugs ClaimRiverstone Resources Sdn Bhd · 2018
- Descendant · 3 generations on · 2 of its ownK190725 Nitrile Examination Glove Sterile Tested for use with Chemotherapy…Riverstone Resources Sdn Bhd · 2019
- Descendant · 4 generations on · 1 of its ownK220250 Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for…Grand Work Plastic Products Co., Ltd. · 2022
- Descendant · 5 generations on · 0 of its ownK232039 Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for…Grand Work Plastic Products Co., Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171093Sterile Nitrile Patient Examination Gloves, PowderfreeSanrea Healthcare Products Pvt, Ltd. · 2017 · cites it directly5descendants
- K180452White Nitrile Examination Glove, Sterile with Chemotherapy Drugs ClaimRiverstone Resources Sdn Bhd · 2018 · 2 generations on3descendants
- K190725Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, WhiteRiverstone Resources Sdn Bhd · 2019 · 3 generations on2descendants
- K220250Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…Grand Work Plastic Products Co., Ltd. · 2022 · 4 generations on1descendant
- K232039Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy…Grand Work Plastic Products Co., Ltd. · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K132006 | Sterile Nitrile Powder Free Examination Glove (Vblu), Sterle Nitrile Powder… | Hartalega Sdn Bhd | 2013 | — |
| +1 | K171093 | Sterile Nitrile Patient Examination Gloves, Powderfree | Sanrea Healthcare Products Pvt, Ltd. | 2017 | — |
| +2 | K180452 | White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim | Riverstone Resources Sdn Bhd | 2018 | — |
| +3 | K190725 | Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs… | Riverstone Resources Sdn Bhd | 2019 | — |
| +4 | K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Grand Work Plastic Products Co., Ltd. | 2022 | — |
| +5 | K232039 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with… | Grand Work Plastic Products Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171093 | Sterile Nitrile Patient Examination Gloves, Powderfree | 2017 | 5 |
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, K171093 (Sanrea Healthcare Products Pvt, Ltd., 2017) has gone furthest, with 5 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. 2013, 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 | — |
https://510kreport.com/device/K132006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132006: Sterile Nitrile Powder Free Examination Glove (Vblu), Sterle Nitrile Powder Free Examination Glove (Ablu).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132006
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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